Consulting
Consulting Services
Compliance made easy
We guide you safely and efficiently through the entire compliance and regulatory approval process—from development to market launch.
Our interdisciplinary team of engineers, computer scientists, quality managers, and regulatory and clinical experts combines technical expertise with many years of project experience in the medical technology and healthcare sectors.
We support startups, medium-sized companies, and international corporations in a pragmatic, solution-oriented manner, working with them as equals.
on product definition, market access, regulatory and clinical approval strategy and reimbursement issues
clinical and performance studies
on all regulatory topics related to product development
for European and international approval
for the creation of technical documentation
on company processes and certifications
on software-related topics
to assume regulatory roles (manufacturer, authorized representative)
clinical or performance evaluations
in the digitalization of your documentation and processes
In the following illustration, we have summarized all the activities required for a medical device manufacturer.
You can see from the color design,
which activities should always remain with the manufacturer (lightest blue)
which activities we can cover with the help of our large, qualified network (light blue)
which activities fall within our portfolio (dark blue)
which activities should be assumed by us at any rate (darkest blue) to be able to live up to our obligation in case we take on the regulatory role of the manufacturer for you.
An Overview of Our Consulting Services
Regulatory Affairs
Immediate Assistance with Regulatory Issues Related to Medical Devices
Our range of services includes:
Our experienced consultants ensure the conformity of your products:
- Determination of current approval requirements and legislation for your target countries
- Preparation of gap analyses on changes to the content of the legislation,
- Evaluation of your product in light of the gap analysis results,
- List of product adjustments to be made,
- Management of product changes,
- Adaptation of the technical documentation to Annex II of the MDR, STED according to IMDRF or other formats and
- Organization and coaching of any required external approval examinations.
We help you to achieve and maintain product conformity:
- Joint creation of a checklist for the required documentation,
- Gap analysis of the available documents / records,
- Creation of a list of work to be carried out regarding documentation and necessary inspections (internal / external),
- Creation / adaptation of the documentation taking into account time-logical aspects,
- Organization / monitoring of necessary audits (internal / external),
- Biological assessment for components and medical devices with patient contact based on the risk-based approach of EN ISO 10993-1,
- Biological assessment for components and medical devices with airway contact based on the risk-based approach of EN ISO 18562-1 and
- Review and approval of the technical documentation by the customer.
We support you in accessing the European Single Market and international markets by means of:
- Development of EU and FDA approval strategies
- Checking the technical documentation against the requirements of the Medical Devices Regulation and the relevant target countries,
- Research for any required reference products and determination of the approval strategy – Preparation of required documents and records,
- Support for regulatory-compliant labeling of your products,
- Organization of translation of documents / records into the target language,
- Support in the planning, implementation and documentation of verification and validation activities,
- Support with planning, implementing and documenting reprocessing and sterilization validations,
- Organization/supervision of necessary audits (internal / external),
- Expansion of the QM system to include the requirements of the target countries, e.g. 21 CFR 820 – Quality System Regulation, MDSAP, etc.,
- Support with the submission of approval documentation,
- Coaching / taking over communication with the competent authorities,
- Preparation of and coaching for any necessary audits / inspections
- Support in the elimination of deviations and
- Coaching / taking over product registration in the respective target countries.
With our help, your products and processes become FDA-compliant:
- Determination of the approval strategy for
- Pre-Market Approval (PMA),
- Pre-Market Notification (510[k]),
- Investigational Device Exemption (IDE),
- Humanitarian Device Exemption (HDE),
- Search for reference products (predicate devices),
- Organization/supervision of necessary tests (internal/external), in particular for bench testing – Preparation of additionally required documents,
- Translation of existing documents into English – Preparation and submission of the required approval file,
- Expansion of the QM system to include the requirements of 21 CFR 820 – Quality System Regulation,
- Support with queries, provision of further documents, if necessary,
- Preparation for an FDA inspection, e.g. performing a mock audit,
- Training your staff in optimal inspection behavior,
- Accompanying the FDA inspection,
- Help with handling warning letters and deviation reports (Form 483) and
- Planning and implementation of corrective actions after the FDA inspection.
Clinical Research Organization – CRO / Clinical Affairs
Our range of services includes:
We ensure the qualifications and expertise relevant for you to carry out the clinical evaluation:
- Analysis of the degree of innovation and relevant clinical risks of your products,
- Feasibility studies prior to product development,
- Identification and evaluation of equivalent products (in accordance with MDCG 2020-5) – also for 510(k) procedures at the FDA,
- Preparation of all relevant documents of a clinical evaluation: Clinical Evaluation Plan (CEP), literature search protocol, literature search report, Clinical Evaluation Report (CER),
- Conducting the clinical evaluation in accordance with the formal requirements of the MDR and MEDDEV 2.7/1 Revision 4,
- Scientific literature search on the planned clinical application (indication/prevalence/state of the art in therapy and diagnosis/alternative treatment options),
- Scientific literature search on equivalent products and relevant, similar products,
- Assessment of the relevance (PICO) and methodological quality of the clinical data obtained,
- Recording and evaluation of post-market surveillance data (PMS),
- Sound advice on the need for a clinical trial, development of the general clinical strategy of the clinical evaluation, tailored to your product, and
- Analysis of the data and assessment of compliance with the essential requirements (safety, performance, benefit/risk, side effects).
Our experienced CRO consultants will organize and support you:
- Formulation of the objectives and hypotheses of a clinical trial / study in accordance with EN ISO 14155,
- Conducting various types of studies (First-in-Man – FIM, Investigator Initiated Trial -IIT, pilot studies, Investigational Device Exemption – IDE, pivotal studies, reimbursement studies, Post Market Clinical Follow-Up Study – PMCF, etc.),
- Preparation of the necessary technical (minimum) documentation,
- Definition of test location and interfaces,
- Drafting of contracts and organization of insurance transactions,
- Obtaining initial approval for the clinical trial,
- Project management of the clinical trial including budget management,
- Continuous monitoring, support and coordination of interfaces,
- Ensuring test documentation, data management and data protection,
- Monitoring compliance with regulatory requirements,
- Evaluation of data from clinical trials according to statistical, biometric and other aspects,
- Preparation or review of the audit report and
- Medical writing including relevant data, regulatory requirements and current formats.
We provide proof of the safety and benefits of your medical device:
- Carrying out the annual market observation activities,
- Analysis of the clinical evaluation, the risk management file and the usability engineering file to ensure they are up to date,
- Assessment of incidents, Field Safety Notifications (FSN), Field Safety Corrective Actions (FSCAs), complaints for relevance to your product and subsequently for your Post Market Surveillance assessment,
- Preparation of Field Safety Notice (FSN) plan and Field Safety Corrective Action (FSCA) plan (Article 89 of the MDR),
- Preparation and maintenance of the post-market surveillance plan in accordance with Article 84 and Annex III of the MDR,
- Preparation and maintenance of the post-market surveillance report in accordance with Article 85 of the MDR,
- Preparation and maintenance of the safety report (“PSUR”) in accordance with Article 86 of the MDR,
- Preparation and maintenance of the Summary of Safety and Clinical Performance (“SSCP”) in accordance with Article 32 of the MDR,
- Preparation and maintenance of the post-marketing clinical follow-up plan/report (“PMCF plan/report”) according to Annex XIV Part B of the MDR and according to the requirements of MDCGs 2020-7 and 2020-8,
- Scientific literature search as a continuation of the clinical evaluation regarding new findings from the literature and in view of safety and benefit for the product to be evaluated,
- Research on current guidelines of professional societies and safety reports in official databases on equivalent and relevant, similar products,
- Risk assessment with regard to reported incidents and
- Support in deciding on the necessity of post-market clinical follow-up studies.
We ensure the qualifications and expertise relevant for you to carry out the performance evaluation:
- Analysis of the degree of innovation and relevant risks of your products,
- Feasibility studies prior to product development,
- Preparation of a performance evaluation plan and a strategy for market approval,
- Performance evaluation according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and MDGC 2022-2 including preparation of the performance evaluation report (PER),
- Scientific literature search on the planned in-vitro diagnostic application (indication / prevalence / state of the art in therapy and diagnosis),
- Scientific literature search on the scientific validity of the analyte and clinical performance of the product to be evaluated,
- Scientific literature search on equivalent products and similar products,
- Evaluation of the relevance and methodological quality of the performance data obtained,
- Recording and evaluation of post-market surveillance data,
- Sound advice on the need for a performance evaluation study, and
- Analysis of the data and assessment of compliance with the essential requirements (safety, performance, benefit/risk, side effects).
We provide proof of the safety and benefits of your in-vitro diagnostics product:
- Carrying out the annual market observation including monitoring of the schedule,
- Analysis of the performance evaluation, the risk management file and the usability engineering file for up-to-dateness,
- Collection, evaluation and reporting of incidents,
- Preparation of Field Safety Notice (FSN) plan, Field Safety Corrective Action (FSCA) plan (Article 82 IVDR),
- Post-market surveillance plan and report in accordance with Articles 79 and 80 IVDR,
- Preparation and maintenance of the safety report (“PSUR”) Article 81 IVDR,
- Scientific literature search as a continuation of the performance evaluation regarding new findings from the literature and in view of safety and benefits for the product to be evaluated,
- Research on current guidelines from professional associations and information from authorities,
- Analysis of product incidents reported to the manufacturer and of comparator products in accordance with Article 84 IVDR,
- Market observation research via international databases,
- Risk assessment with regard to reported incidents and
- Support in deciding on the necessity of post-market performance follow-up studies.
Product Life Cycle Management / Quality Management
Our range of services includes:
Benefit from our long-term experience in implementing efficient QM systems that meet your requirements:
- Development of a customized QM system according to
- EN ISO 13485,
- cGMP e.g. 21 CFR Part 820 (QSMR),
- European medical device regulations (MDR and IVDR),
- further requirements coming from international sets of rules, e.g. EN ISO 9001, EN 9100, EN ISO/IEC 27001,
- Implementation of all processes required for development, production and marketing,
- Training of the new QM system, adapted to the different user groups,
- Accompanying support for your employees during the introductory phase,
- Support with internal audits and management reviews,
- Support during certification or surveillance audits,
- Long-term support in establishing and optimizing your QM system and
- Support in the selection, qualification and monitoring of your distributors and suppliers at home and abroad.
We also support you in qualifying as a distributor and supplier and equip you with efficient QM systems that comply with the requirements:
- for distributors:
establishment of an MDR-compliant (partial) QM system, which may also include non-European requirements, and - for suppliers:
Advice during introduction of a new QM system or the expansion of an existing one, e.g. from EN ISO 9001 or IATF 16949 to EN ISO 13485 or 21 CFR 820.
Changes to regulatory requirements are part of everyday life in the development, manufacture and approval of medical devices. Understanding the consequences quickly and processing them for the customer in an understandable and results-oriented manner is a familiar task for seleon’s consultants, which we implement quickly and efficiently.
We implement new processes for you or optimize existing ones:
- Preparation of a delta/gap analysis of existing processes to new/changed regulatory requirements,
- Design and implementation of the necessary new or modified processes or process elements,
- Adaptation of the associated process and QM-relevant documentation,
- Provision of traceability analyses for the process-related requirements from the applicable standards,
- Training of the new or modified processes,
- Coaching for external audits and
- Support in the implementation of potential improvements.
Our experienced consultants draw on the company’s own knowledge from the two other core areas of development and production of sophisticated medical technology as well as from numerous different projects carried out.
We support you with:
- Recording and analyzing your existing processes (consistency and logic, number of roles involved, interfaces, media breaks, etc.),
- Development of a new and efficient process model that considers all areas, disciplines, roles, project types and processes involved,
- Presentation of the new processes with modern visualization tools and
- Creation of lean and clear role-based and therefore person-neutral processes that fulfill all necessary regulatory requirements (e.g. CE, FDA).
Our in-depth expertise is based on the realization of numerous international development and manufacturing projects in medical technology. Our consulting services cover the entire product lifecycle management (PLM) process.
We support you with:
- Determining the efficiency potential of your PLM processes within structured interviews with your top performers,
- Analysis and evaluation of process and interface complexity and efficiency,
- Introduction, evaluation and optimization of key performance indicators (KPIs) in the entire PLM area,
- Analysis, evaluation and optimization of cost structures,
- Targeted implementation of measures to reduce rework,
- Optimization of your product portfolio through platform concepts, variant optimization and complexity reduction as well as
- Consulting and project support in the selection, configuration, introduction and optimization of software tools to support your PLM processes (ALM tools such as POLARION, Greenlight Guru, JIRA, Confluence, PDM tools, etc.) – see also our digitization section
Due to the increasing complexity of medical devices, the need for consistent and methodically prepared documentation (design control) is becoming ever greater. The FDA in particular, but also increasingly the notified bodies in Europe, are showing a growing tendency to reject incomplete or non-transparent approval documents.
Our approach is to create a closer fusion of device architecture and life cycle activities with the documents accompanying development.
We achieve this through a consistent layer model that makes use of the logical levels of the V-model and combines this with a modularization concept that provides a consistent document set for each subsystem of the medical device. The documents belonging to a subsystem are clearly displayed in a design control chart, which makes it much easier for you to carry out a successful audit.
Our experienced consultants ensure the long-term safety of your products:
- Risk management according to EN ISO 14971, DIN ISO 31000,
- Carrying out preliminary hazard analyses (PHA) on the basis of a functional analysis,
- substantiation of the medical risks with clinical data,
- Carrying out product-related risk analyses (design FMEA) for assemblies, products and systems,
- Carrying out process-related risk analyses (process FMEA) for the entire supply chain,
- Definition of the essential performance characteristics according to the IEC / EN 60601-1 family of standards,
- Conception of safety concepts and specifications (safety cases) and
- Creation of a security/safety-related architecture for PEMS and PESS.
We support you with usability engineering activities for your medical device according to the life cycle phase
- Creation of the Use Specification,
- Identification, documentation and handling of safety-relevant features and use errors,
- Identification, documentation and treatment of hazard-related use scenarios,
- Identification and documentation of the User Interface Specification,
- Planning, implementation and evaluation of formative evaluations and summative evaluations as well as
- Creation of the usability engineering file.
Our auditors bring external know-how to your company:
- Joint definition of the audit scope and the company units to be assessed and preparation of the audit schedule,
- Review and analysis of the documents / records provided on processes and products,
- Conducting audits to evaluate the effectiveness of the QM system and / or the technical documentation at the customer’s premises,
- Conducting supplier audits to ensure compliance with process specifications and the specified product quality and documentation,
- Evaluation of the root cause analyses, corrections and corrective measures carried out and
- Evaluation of the effectiveness of corrective and preventive measures.
Our consultants will prepare you and support you during audits and inspections:
- Joint review of the audit schedule with the client, formulation of change requests, if necessary,
- Review and analysis of the documents / records to be provided for processes and products,
- Carrying out a pre-audit / mock audit and preparing a gap analysis,
- Support in the elimination of possible existing deviations/gaps,
- Support / coaching during the external audit / inspection,
- Joint review of the audit report with the customer, formulation of change requests, if necessary,
- Support with the root cause analysis, corrections and corrective actions (CAPA) and
- Support for the effectiveness assessment of corrective and preventive actions (CAPA).
Our consultants will prepare you specifically for MDSAP audits:
- Perform mock audits using the same process based MDSAP audit model used by the approved auditing organizations,
- Identification of gaps in the MDSAP requirements and development of specific solutions to close the gaps,
- Coaching on the application of risk-based thinking,
- Development and review of MDSAP audit checklists,
- Comparison of your internal audits with the MDSAP process and
- Assessment of the proper registration of your products in the participating countries and fulfillment of the MDSAP reporting requirements
Medical Software Consulting
Our range of services includes:
Benefit from our long-term experience in implementing efficient and requirements-compliant software lifecycle processes – from embedded software on the controllers of a medical device or in the graphical user interface (GUI), as standalone software (SaMD = software as a medical device, SWMD), as network, database and cloud software or in the Internet of Medical Things (IoMT), as a medical app, German digital health application (DiGA), German digital care application (DiPA) or health software:
- Development of customized processes according to
- EN 82304-1 (system layer for health software/Standalone software),
- EN 62304 (Software life cycle processes for medical device software),
- EN IEC 81001-5-1 (Security activities in the life cycle of health software),
- Implementation of all processes required for the specification, development, verification, validation, deployment and product care / maintenance of the software
- Training on software lifecycle processes,
- Support with reviews, internal and external audits, assistance with certification audits and
- Long-term support in establishing and optimizing your software lifecycle processes.
Regulatory Cybersecurity Affairs – we support you with:
- Teaching the basics and terms as well as understanding safety & security,
- Definition of your protection goals to avert hazards,
- Identification, understanding and implementation of regulatory and normative requirements for the IT security of medical devices in accordance with regulations (MDR, IVDR, MDCG-2019-16, MPBetreibV, FDA) as well as standards and guidelines (IEC 81001-5-1, IEC 62443-4-1, ISO/IEC 27001, IEC 60601-1, IEC 80001-1 for manufacturers, ISO 27034, AMI TIR 57/97 etc.),
- Establishing a secure development and product life cycle: ensuring and maintaining cybersecurity/IT security and monitoring it after it has been placed on the market,
- Identification and assessment of risks and threats (security risk management in accordance with EN IEC 81001-5-1, safety risk management in accordance with ISO 14971) and
- Compliance with the requirements for data protection of patient data (GDPR; HIPAA etc.).
Even older medical devices featuring software or insufficiently documented software are not lost for approval. We help you with
- the subsequent documentation of the software according to the currently valid requirements or
- the application of the legacy software approach to bridge transitional periods up to your new products.
A combination of post-documentation and simultaneous digitization is often a sensible option. See also our digitization section
What distinguishes the specification, development, verification, validation and approval of medical apps or health software from the usually already well-established procedure for embedded software?
We set up processes tailored to these software products with the corresponding documentation and support you in all life cycle phases of your medical app or health software.
And who says that there are no medical apps in risk class I according to MDR?
We offer approaches that comply with the requirements but are still streamlined.
Health software for use in the healthcare sector that is not a medical device is also subject to process, product and documentation requirements. We help to implement a practicable, risk-based approach that ensures safety, performance and the intended benefits.
New reimbursement concepts are intended to ensure digitalization in medical diagnostics and therapy as well as facilitate care.
Our digital health experts support you with
- Development and approval as a medical device (a mandatory requirement for DiGAs),
- Implementation of the special technical requirements for DiGA and DiPA,
- Development of clinical & reimbursement concepts (Reimbursement),
- Implementation of the special clinical requirements for DiGA and DiPA and
- Implementation of the application and authorization procedure with the BfArM.
Artificial intelligence (AI)/machine learning (ML) has numerous applications in medical devices. These are often health software (SWMD, SaMD), but this technology is also increasingly being used in devices and systems (embedded SW).
Our human intelligence (MI) supports you with:
- Communicating the regulatory basis for AI-based medical devices,
- Identifying, understanding and implementing the regulatory requirements for AI/ML in medical technology, in particular
- European AI Act and other European regulatory concepts,
- Regulatory approaches of the FDA and other regional regulatory authorities,
- General and medical device-specific AI/ML standards,
- Expansion of the quality management system for AI/ML medical devices,
- Adaptation of product/software lifecycle processes to AI/ML technology
- Establishment of data management for training, validation and tuning of the AI/ML system,
- Extension of the required technical documentation and
- Approval of AI/ML medical devices in the EU and the USA.
Digitalization
Our range of services includes:
We support you in the initial assessment of the digitization status in your company with the following steps:
- Analysis of the current status in the context of the digitalization of your company,
- Holistic determination of needs and requirements,
- Interviews with stakeholders and
- Consolidation and analysis of the results.
We work with you to determine the innovation potential and challenges in the context of digitalization in your company:
- Identification of potential innovations in the four levels of digitalization:
digital processes, digital products, digital business models, digital networking, - Identifying the necessary changes in the company and
- Evaluation of the influence of the changes brought about by digitalization
in the company.
We work with you to develop a suitable digitalization strategy for your company:
- Outline an individual strategy, taking into account the objectives in the levels and dimensions of digitalization,
- Designing your iterative roadmap for digitization and
- Communicating your digital strategy.
We support you in the implementation of your digitalization strategy by:
- Creation of your project plan with sequences and milestones and
- Support in the project phases è Best practice and migration.
Our regulatory specialists team up with the digitalization experts for the:
- Analysis of your technical documentation and development of a concept for converting the content of documents into data,
- Development and realization of transfer projects for your technical documentation together with the relevant tool providers and
- Support with the creation or transfer of your technical documentation to an ALM/PLM system
We work with you to digitize your processes with new systems:
- Process optimization taking into account the relevant tools (coordinating processes and tools),
- Development and realization of transfer projects together with the relevant tool providers and
- Support with the creation and/or conversion of your quality management system into an eQMS.
The best digital tool is useless if it has not been validated (before its first use). We are happy to help you with this often-unpopular topic:
- Basic training courses on computer system validation,
- Analysis of the need for action in relation to the requirements of EN ISO 13485 and other requirements of the MDSAP countries (USA, Canada, Japan, Brazil, Australia),
- Support with the procedural implementation of CSV in the QM system,
- Support in identifying the IT systems in the company,
- Creation of a validation master plan,
- Risk assessment of the identified systems as a basis for deciding which CSV activities need to be carried out,
- Validation of systems assessed as requiring validation according to a risk-based approach and
- Support with auditing.
Assumption of regulatory roles
Our range of services includes:
Medical technology start-ups often face the challenge of bringing their product to market as quickly as possible with limited human resources.
They often do not yet have the personnel / expertise on board to set up their own complete quality management system and the required regulatory processes.
It is also not always planned to set up a separate development and/or production area – for example, if the company is to be sold by the founders after the initial successes and the product ramp-up.
In such a case, seleon can assume the role of the legal manufacturer for a certain period of time or the entire product life cycle and relieve its customer.
However, such a solution can also be of interest to established medical device manufacturers when it comes to medical devices that complement their portfolio but are not part of their actual core business and they do not want to build up personnel / expertise for this.
Assuming the role of the legal manufacturer is not tied to the commissioning of a development and/or production project at seleon – but it makes the whole thing considerably easier, as we know the medical device we develop and/or manufacture best and are therefore best able to comprehend the risk structure.
Do you want to bring your medical devices into the European Union (EU)?
Then we are a trustworthy partner who meets the significantly increased requirements for the authorized representative (EC-REP) as a result of the MDR and IVDR very well thanks to our regulatory expertise and established processes.
We are happy to take on this important role for you and be your regulatory face in the European Union.
Are you a startup? We can help you with a clear go-to-market strategy.
We support you in all fields. Internally and with our many network partners:
- Concept workshops on product definition, market access, clinical & regulatory strategy and reimbursement topics in the discovery phase,
- Support with financing via investors or funding,
- Gradual establishment of a tailored quality management system – initially focused on the development-relevant processes and later complete as approval approaches,
- Development of medical devices, in-vitro diagnostics, medical software and medical apps,
- Preparation of clinical evaluations or performance evaluations,
- Conducting clinical trials in all product life cycle phases,
- Organization of the design transfer and the pilot series,
- Implementation of formative and summative evaluations and other design validation activities,
- Creation and maintenance of technical documentation for the various target markets,
- Support with international product approval,
- Organization of the ramp-up of production and the transition to series production,
- Help with market placement and reimbursement issues and
- Support in change management and product maintenance
Regulatory & IP Due Diligence Services
Our range of services includes:
Our consultants evaluate with a neutral outside perspective:
- the approval concept and the regulatory maturity level of medical devices,
- the practicability, quality and completeness of the system and process documentation and
- the quality and completeness of the technical documentation of medical devices.
The following procedure has proven to be very effective:
- Visit to get to know the company, its employees, its products and processes,
- Review/analysis of the documents provided,
- Conducting interviews to assess the service providers,
- Checking processes for conformity with requirements,
- Review/analysis of documents/records for evaluation,
- Preparation of the expert opinion/evaluation,
- Presentation of the expert opinion/assessment to the client and
- Support in the further development and optimization of products and processes.
Training courses
Qualified employees are the prerequisite for successful work. We support you with in-house training on a wide range of issues:
- QM systems for medical device manufacturers, distributors and suppliers,
- Risk management for medical devices according to EN ISO 14971,
- Development of active medical devices in conformity with EN 60601-1,
- Software development in accordance with EN 62304 and EN 60601-1, chapter 14,
- Software validation in accordance with MDR, IVDR, FDA Design Control, EN ISO 13485, EN 82304-1, EN 60601-1, Chapter 14,
- Interoperability of medical devices according to ISO/IEEE 11073, AAMI/ANSI/UL 2800, DICOM, HL 7,
- Usability in accordance with EN 60601-1-6 and EN 62366-1,
- ISO/FDA-compliant product and software development (design control),
- Regulatory affairs training for worldwide approval,
- Post Market Surveillance, Vigilance and Post Market Clinical Follow-up,
- Person responsible for regulatory compliance (Responsible Person) according to Article 15 MDR/IVDR,
- German Medical device advisor according to § 83 MPDG,
- Internal and supplier auditor training and
- Training on conducting clinical assessments in accordance with MDR and MEDDEV 2.7/1 Revision 4.
Sustainable Medical Technology
We align companies and products in the medical technology sector with current environmental regulations and new sustainability requirements.
Driven by increasingly comprehensive regulations, as well as social upheavals, sustainable business practices are receiving growing attention in the medical technology sector. Are you receiving more and more customer inquiries about the ecological and social impacts and corporate policies? Do you need a solid data basis for the impacts of your products throughout their entire lifecycle? Or do you feel burdened by the increasing sustainability regulations? Our cross-functional sustainability team can certainly provide support:
We assess the environmental impacts and social compatibility of your products throughout their entire lifecycle and develop measures to reduce negative effects:
- Information sessions on topics such as circular economy and reuse of medical products
- Benchmarking the ecological impacts of products according to Greenhouse Gas Protocol (GHG) and Life Cycle Assessment (LCA) according to ISO 14040/44
- Implementation of sustainable product development with appropriate requirements management and application of eco-design through project management, process implementation, and training
- Project and service development in the context of sustainable business models and technologies
- Supplier management with risk analyses, transparency models, and supplier audits
We provide clarity in the increasingly dense jungle of sustainability regulations and ensure your compliance:
- Information sessions on applicable and emerging environmental regulations such as CSRD, CSDDD / LkSG, Eco Design Regulation, Packaging and Packaging Waste Regulation, and much more
- Ensuring your material compliance according to current regulations (e.g., RoHS, REACH) as well as implementing a material compliance strategy with associated processes
- GAP analyses and risk analyses for emerging regulations
- Implementation of sustainability reporting processes (e.g., according to CSRD)
- Support with double materiality analysis and stakeholder analysis
We support you in certification according to environmental standards by developing appropriate strategies and integrating processes and software:
- Development and integration of a sustainability strategy
- Support in certification with recognized sustainability seals (e.g., EcoVadis)
- Integration and internal auditing of sustainability management systems according to ISO 14001
- Support in selecting and implementing appropriate software for reporting and carbon accounting
- Conducting a cost-benefit analysis for sustainability measures
- Support in internal sustainability communication and corresponding knowledge building