Regulatory Services for Medical Devices and IVDs Across the Entire Product Life Cycle
From initial regulatory classification to post-market surveillance: Metecon brings together the necessary disciplines for medical devices and IVDs throughout the entire product life cycle. This ensures that requirements, documentation, risks, and changes remain consistently aligned.
Regulatory Documentation - Consistently Aligned
Regulatory requirements are implemented across various areas of performance. Technical documentation, risk management, verification and validation, clinical evaluation or performance evaluation, and post-market activities must therefore be coordinated in a technically consistent manner.
At Metecon, the experts required for this work closely together. Findings and evidence from one area of performance are taken into account in the relevant regulatory disciplines. This results in consistent documentation and chains of reasoning, rather than isolated, individual solutions.
Quality Management, Strategy & Regulatory Representation
Structures, decisions, and responsibilities for sustainable regulatory work.
QMS & Auditing
Establish, further develop, and efficiently operate quality management systems in accordance with ISO 13485 or ISO 9001, tailored to the organization and regulatory requirements.
QMS in accordance with ISO 13485 / ISO 9001→Strategic Consulting
Making forward-looking regulatory decisions and translating them into sustainable structures: from product and market strategy to organization, resources, and change.
Strategic Consulting →EU-REP/EC-REP · CH-REP · PRRC
Authorized representative roles and responsible person—all from a single source via the Metecon Group.
EU-REP, CH-REP & PRRC →Testing, Evaluating, and Verifying
Regulatory evidence supporting the safety and performance of your product.
Risk Management
Systematically identifying, assessing, controlling, and monitoring risks in accordance with ISO 14971 throughout the entire product life cycle.
Risk Management ISO 14971 →Biosafety
Strategically assessing biological safety in accordance with ISO 10993, planing the necessary tests in a targeted manner, and documenting them in a traceable way.
Biological Safety ISO 10993 →Usability Engineering
Systematically developing and demonstrating usability in accordance with IEC 62366-1, from the analysis of use-related risks to summative evaluation.
Usability According to IEC 62366-1 →Verification & Validation
Planing test strategies, coordinating tests, and documenting results in a traceable manner.
Verification & Validation →Clinical Evaluation
Systematically planning, evaluating, and keeping clinical evidence up to date throughout the product life cycle in accordance with the MDR.
Clinical Evaluation →Performance Evaluation (IVD)
Evaluating and documenting scientific validity as well as analytical and clinical performance in accordance with the IVDR, including performance studies and PMPF, where required.
IVD Performance Evaluation →Software, AI & Cybersecurity
Regulatory requirements for every software configuration— as a product, within a product, and in a supporting role.
Medical Device Software (MDSW)
Establishing and documenting a regulatory framework for software development throughout the entire software life cycle and in accordance with the relevant standards.
Medical Device Software →AI Regulation
Consolidating requirements from the AI Act, MDR/IVDR, and software regulations—from classification and data strategy to risk management, QMS integration, and documentation.
AI Regulation Under the AI Act →Cybersecurity
Establishing regulatory cybersecurity requirements from development through the post-market process for EU and international markets.
Cybersecurity & Information Security →Software Validation
Validating supporting software and computer-based systems using a risk-based approach—in a traceable, efficient manner that meets the applicable requirements.
Software Validation According to CSA →Technical Documentation & Market Access
Documentation and regulatory procedures for accessing your target markets.
Technical Documentation
Structuring, completing, and updating product documentation in accordance with the MDR/IVDR.
Technical Documentation in accordance with MDR/IVDR →EU Conformity Assessment (MD)
Preparing for CE marking in a structured manner: Defining procedures, compiling the necessary documentation, and supporting the conformity assessment process.
EU Conformity Assessment for Medical Devices →EU Conformity Assessment (IVD)
Implementing the appropriate IVDR conformity assessment pathway: from classification and performance evidence to supporting the notified body procedure, if required.
EU Conformity Assessment for IVD →International Approval
Coordinating market access strategies; leverage data for additional markets—FDA, NMPA, ANVISA, and others
International Approval →Post-Market Surveillance
The closed loop: Collecting and evaluating market data , and feeding it back into risk management, clinical evaluation, performance evaluation, and technical documentation.
Post-Market Surveillance
Systematic planing, evaluation, and updating the PMS plan, data sources, and reports (PSUR/PMS Report).
Post-Market Surveillance →PMCF / PMPF
Post-market clinical follow-up for medical devices and post-market performance follow-up for IVDs—from planning and data collection to analysis and reporting.
PMCF & PMPF →Vigilance & CAPA
Reliably evaluatin reporting requirements, analyzing causes in a structured manner, and effectively managing corrective and preventive actions.
Pharmacovigilance & CAPA →Interdisciplinary Regulatory Expertise That Works Together
Everything From a Single Source
Our specialized disciplines operate based on a shared understanding of requirements, risks, evidence, and changes. This ensures that technical documentation, risk management, verification and validation (V&V), clinical affairs, and post-market activities remain consistently aligned.
Dialogue on Equal Terms
We work closely with your team, explain decision options in a clear and understandable way, and implement the decisions that are made. Upon request, we also handle communication with notified bodies and regulatory authorities.
Knowledge That Lasts
We share knowledge within the project and build on it through individual workshops and training sessions. This fosters regulatory expertise within the team, enabling decisions to be made increasingly independently.
Part of the Metecon Group: 25+ years of regulatory experience, 50+ compliance experts, offices in Mannheim and Bern – learn more about us →
Frequently Asked Questions About Regulatory Services
What regulatory services does Metecon offer?
Metecon supports manufacturers with the full range of regulatory services for medical devices and IVDs: technical documentation and EU conformity assessment, international approval, software regulations (MDSW, AI, cybersecurity, software validation), verification & validation, usability, biological safety, clinical evaluation, performance evaluation, risk management, post-market surveillance including PMCF/PMPF and vigilance/CAPA, as well as QMS & auditing, representative services (EU-REP/EC-REP, CH-REP, PRRC), and strategic consulting.
Who are these services intended for?
For manufacturers of medical devices and in-vitro diagnostic devices of all sizes—from startups to international corporations—as well as for all software configurations: software as a medical device, software embedded in a product, and supporting software. MedTech manufacturers—from SMEs to international corporations—derive the greatest value from collaborating with Metecon when regulatory requirements across a broad product portfolio or multiple departments need to be integrated.
What sets Metecon apart from specialized individual providers?
Integration: At Metecon, the relevant regulatory disciplines work closely together—from classification through development and testing to post-market surveillance. This ensures that regulatory requirements, supporting documentation, risks, and changes are consistently addressed throughout the entire product life cycle—across disciplinary boundaries rather than in isolation within individual disciplines.
Can I also request just individual services?
Yes. Our services can be ordered individually or in combination—ranging from a one-time gap analysis or individual documents to comprehensive support for a regulatory project. Projects often begin with an analysis and then evolve as needed.
Does Metecon also provide support for the FDA and international markets?
Yes. In addition to MDR and IVDR, we assist with submissions to the FDA and other international markets, including China, Brazil, Japan, Canada, and Australia. In doing so, we coordinate the market access strategy and assess which existing documentation can be used for additional approvals.
How do I get started with this collaboration?
With a free initial consultation: You describe your product and your situation to us. Together, we’ll clarify the regulatory requirements and discuss the best next steps.
Which service is right for your situation?
Start with a free initial consultation: You describe your situation to us, we work together to clarify your regulatory needs, and discuss what the next steps should be.
- 30 minutes, free of charge and with no obligation
- Assessment specific to one area or spanning multiple/all areas
- Specific recommendations for your next steps
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
