Regulatory Compliance Partner for Medical Devices and IVDs
From the initial concept to post-market surveillance: Metecon supports manufacturers of medical devices and in-vitro diagnostic medical devices with strategic consulting, regulatory services, and the digitalization of these processes—to facilitate market access, international expansion, and the development of a regulatory organization capable of effective long-term action.
Comprehensively Manage Regulatory Compliance for Medical Devices and IVDs
New markets, technologies, and changing regulatory requirements are increasing complexity. At the same time, existing products must be kept on the market safely, documentation must remain up to date, and regulatory processes must remain efficiently manageable. Technical documentation, risk management, verification and validation, clinical affairs, and post-market activities are not isolated from one another: Regulatory requirements and supporting documentation are intertwined, build upon one another, and influence subsequent regulatory decisions.
Metecon combines regulatory expertise across disciplines and throughout the product life cycle. This results in consistent documentation and structures that fit together seamlessly—during audits, in regulatory submissions, and in day-to-day operations.
Strategic Consulting, Regulatory Services, and Digital Transformation
Three approaches that can be used individually or combined, depending on the situation.
Strategic Management
Regulatory decisions rarely affect just a single product or document. Metecon helps you prioritize requirements, prepare well-founded decisions, and derive an actionable regulatory strategy from them.
Strategic Consulting →Regulatory Implementation
From development and conformity assessment to technical documentation, clinical affairs, and post-market surveillance: Our specialist teams work together seamlessly, provide the necessary documentation, and coordinate evidence and activities.
All 19 Services →Digitalizing Processes
Metecon supports you every step of the way—from analyzing regulatory processes, through defining the target state and selecting vendor-neutral tools, to implementing and optimizing digitalized workflows.
Regulatory Digitalization →Regulatory Expertise Throughout the Entire Product Life Cycle
19 service areas, one principle: documentation consisting of individual components that build on one another and fit together across disciplines.
Technical Documentation & Registration/Approval
submission-ready files in accordance with MDR/IVDR, EU conformity assessment, and international market access—10+ international markets
Software, AI & Cybersecurity
IEC 62304/82304-1, AI Act, cybersecurity, and risk-based software validation (CSA)—for every software configuration.
Test, Evaluate, and Verify
risk management (ISO 14971), biosafety (ISO 10993), usability engineering per IEC 62366-1, verification & validation, clinical evaluation / IVD performance evaluation.
Post-Market Surveillance
PMS, PMCF/PMPF, and vigilance & CAPA as a closed-loop process—collection of market data, evaluation, and feedback into the file.
Quality Management, Representation & Strategy
QMS in accordance with ISO 13485, EU-REP · CH-REP · PRRC through the Metecon Group, and strategic consulting to help you chart your course.
Ready to get your first product approved?
Startups and first-time manufacturers begin by defining their classification, regulatory path, and portfolio strategy—before any work is done.
Regulatory Digitalization
Establishing Digital and Controllable Regulatory Processes
Documents are hard to find, approvals take too long, and information is maintained in multiple places. A new system can help—but it can also perpetuate unclear processes, data, and responsibilities in the digital realm.
That’s why, at Metecon, regulatory digitalization doesn’t start with a tool, but with the question of how regulatory work should function in the future. We support you every step of the way—from process analysis and defining your vision, through vendor-neutral tool selection, to implementation and optimization.
Processes and Target Vision
Analyzing existing processes, identifying and addressing weaknesses, and defining how regulatory work should be conducted more efficiently, transparently, and with greater control in the future.
Tool Selection
Systematically identifying requirements and comparing suitable solutions in a vendor-neutral manner—to ensure the system aligns with processes, data, organizational structure, and regulatory requirements.
Implementation & Optimization
Implementing digital workflows, establishing responsibilities and usage, and continuing to refine processes as operations continue.
Coordinated Planning of International Market Entry Strategies
If you want to enter multiple markets, you should not plan regulatory approvals in isolation. Metecon helps you compare regulatory requirements early on, leverage existing files, supporting documentation, and data for additional markets, and plan for additional requirements in a targeted manner. This results in a consistent regulatory strategy that links new market entries with existing regulatory documentation.
Ensuring Compliance & Maintaining the Ability to Act
New requirements, changes in the product portfolio, international expansion, or staffing shortages can quickly put pressure on established processes. It is therefore crucial not only to be compliant today, but also to be able to assess changes from a regulatory perspective, prioritize them, and implement them in a controlled manner. Metecon supports manufacturers in further developing regulatory structures, processes, and capabilities so that their organizations remain capable of acting effectively even under changing conditions.
- Executive Briefing: Identifying Vulnerabilities Before They Become Critical
- Self-Check: 7 Questions to Assess Your Current Status
- Initial Consultation: Assessment by Experienced Experts
Request the Executive Briefing PDF
Get started with the concise PDF for executive management and RA/QM.
More on the Overarching Topic: Regulatory Resilience
Regulatory Strategy and Implementation from a Single Source
Metecon combines strategic consulting, operational regulatory expertise, and the digitalization of regulatory processes—across disciplines and in a way that ensures solutions work together seamlessly. About Us →
Interdisciplinary
We bring together the expertise that your regulatory issue truly requires—across departments and throughout the product life cycle.
Flexible Collaboration
From individual work packages to comprehensive support for your team: the scope and structure are tailored to your situation.
Manufacturer-Focused
We consider regulatory requirements in the context of your products, processes, markets, and organization.
Free Practical Resources
White paper “An Overview of Regulatory Services” and other downloads to get you started.
What Customers Value About Working With Us
“We’ve been working with the Metecon team on our projects for years. It’s very important to have a reliable and competent partner by your side. Their wide-ranging expertise and the results they deliver consistently justify our decision to choose Metecon.”
“With Metecon, we received personalized support tailored to our needs, knowledgeable discussion partners, and, as a result, outcomes that were accepted during the audit. The project team worked very independently and was always willing to go the extra mile with us. We look forward to future projects!”
“From strategic planning to implementation, Metecon was a strong partner for our IVD project. Their timely, transparent communication and practical solutions were very helpful to our team. We were able to submit the content we developed together to our Notified Body without needing to ask for clarification. A result that speaks for itself.”
“Working with Metecon was an excellent experience from start to finish. Communication was always clear and transparent, so we felt well-informed at every stage of the project. Schedules and milestones were reliably met, which gave us great confidence in the entire process. The final results were comprehensive, well-structured, and demonstrated a high level of professionalism and expertise. Thanks to the team’s dedication, the project was a complete success.”
“A professional and collaborative partnership that has helped us make significant progress in implementing the MDR, including the MDCG guidance documents. Metecon works in a goal-oriented manner, tailoring its approach to our needs and operating very efficiently.”
Regulatory Updates and News from Metecon
Insights
expert articles, analyses, and insights on regulatory developments, digitalization, and strategic issues in medical technology
Digital Transformation Partnerships
vendor-neutral consulting, implementation with strong partners—for digital regulatory processes, suitable system architectures, and future-proof workflows.
Events & Presentations
Meet Metecon at trade shows, conferences, and industry events—as an exhibitor, speaker, or visitor.
Frequently Asked Questions About Metecon
What does Metecon do?
Metecon supports manufacturers of medical devices and in-vitro diagnostic medical devices with regulatory compliance. We combine strategic consulting, regulatory services across the entire product life cycle, and the digitalization of regulatory processes—from market access to post-market surveillance—with more than 50 compliance experts and offices in Mannheim and Bern.
Who are Metecon's services intended for?
For manufacturers of medical devices and in-vitro diagnostic medical devices of all sizes—from startups to international corporations. 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 specialized areas need to be integrated.
What services does Metecon offer?
Metecon covers 19 interrelated service areas: from strategic consulting, EU conformity assessment, and international approvals, through technical documentation, risk management, verification and validation, biosafety, and usability engineering, to software regulation, clinical affairs, and PMS, PMCF/PMPF, and vigilance & CAPA. In addition, the company offers QMS & auditing as well as representative services (EU-REP/CH-REP, PRRC).
Does Metecon also provide support for international approvals?
Yes. Metecon supports manufacturers in gaining market access both within and outside the EU. Together, we plan which markets can be entered in a way that makes sense from a regulatory perspective, identify the applicable requirements, and determine which existing files, evidence, and data can be utilized for further market authorizations. In this way, preparations for accessing international markets can be coordinated rather than handled in isolation.
Does Metecon also provide support for the digitalization of regulatory processes?
Yes. Metecon supports manufacturers from the analysis of existing regulatory processes and the development of a target vision, through vendor-neutral tool selection, to the implementation and optimization of digital workflows. The focus is not on individual systems, but on the interplay of processes, data, responsibilities, and regulatory requirements.
What sets Metecon apart from specialized individual providers?
Metecon combines strategic consulting with operational regulatory expertise across various disciplines. Regulatory submissions and activities are not handled in isolation but are coordinated—from development and conformity assessment through post-market surveillance. This allows manufacturers to outsource individual tasks while simultaneously drawing on interdisciplinary expertise that takes regulatory contexts into account.
Could Metecon also take on individual regulatory tasks?
Yes. Our collaboration ranges from clearly defined work packages and specific technical issues to long-term support for regulatory teams. Which experts are involved and the scope of our collaboration depend on your specific situation.
How do I start working with Metecon?
We start with a no-obligation initial consultation. You describe your current situation and concerns to us, and together we determine what kind of support you need and, if necessary, bring in the appropriate experts. This allows us to identify early on what the next logical step is for your situation.
Let's talk about your project.
Start with a free initial consultation—we’ll assess your product’s regulatory status and recommend the next steps. Complexity then quickly gives way to clarity.
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
