This year’s Medica fair once again demonstrated why it remains one of the most influential events in the medical technology world. From visionary start-ups to seasoned industry leaders, the entire ecosystem was buzzing with new ideas, emerging technologies, and a clear drive toward safer, smarter, and more efficient healthcare solutions.
What stood out most this year was not only the pace of innovation — especially in digital health and neonatal technologies — but the growing recognition that regulatory strategy and quality management are now essential building blocks of successful product development, not final hurdles.
Startups Are Innovating Fast — and Prioritizing Regulatory Strategy Earlier Than Ever
The start-up hall at Medica was exceptionally active. Many early-stage teams showcased impressive digital tools, diagnostic solutions, and neonatal devices addressing meaningful clinical needs. What was even more encouraging was how many of these companies were already thinking about MDR readiness, CE marking pathways, and their long-term regulatory strategy.
For new innovators, the complexity of MDR can be overwhelming — but starting the QA/RA process early makes the entire journey smoother. Discussions at Medica revealed a clear trend: more start-ups are seeking regulatory partners who can integrate directly into their development process and guide them from concept to market entry.
Building International Connections Across QA/RA, CRO, and Testing Partners
In addition to engaging with innovators, Medica offered an opportunity to connect with potential partners across the medical device ecosystem, including:
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International QA/RA service providers
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EC REP and UK REP organizations
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CROs supporting clinical investigations
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Biocompatibility and laboratory testing providers
These interactions highlighted how essential collaboration has become in modern medical device development. Companies increasingly rely on well-coordinated partnerships to meet MDR requirements efficiently and maintain compliance throughout the device lifecycle.
How MDS Supports Companies Across the Entire MDR Journey
With MDR requirements continuing to evolve — especially for software, AI-based devices, and high-risk products — we saw a clear need for experienced, flexible support that adapts to the company’s stage and product type.
At MDS, we offer a comprehensive suite of QA/RA services, including:
Technical Documentation & CE Marking
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Full preparation and maintenance of MDR Technical Files
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Structured document systems and product-specific templates
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Verification and validation planning, including coordination with accredited labs
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Support with EUDAMED registration and UDI implementation
Clinical & Biological Evaluation
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Development of Clinical Evaluation Plans (CEP)
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Authoring of Clinical Evaluation Reports (CER) aligned with MDCG guidance
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Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER)
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Literature search, appraisal, and analysis
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Coordination of testing, chemical characterization, and risk assessments
Quality Management Systems
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ISO 13485 implementation and audit readiness
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Acting as an outsourced Quality Manager or PRRC
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Internal audit support and supplier audit programs
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Transition support during staff or process changes
Clinical Research & CRO Services
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Early clinical strategy and feasibility assessments
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Protocol development and site selection
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Monitoring, documentation, and Clinical Investigation Report preparation
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Post-market clinical follow-up (PMCF) planning
Due Diligence & Early-Phase Evaluation
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Investor and procurement due diligence
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Regulatory feasibility assessments
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Intended use, market suitability, and risk profiling
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Strategic pathway planning (EU, US, UK, and global markets)
Whether you are a first-time developer or an established manufacturer expanding into new markets, MDS provides hands-on, practical, and collaborative support to strengthen your regulatory foundations and accelerate your route to market.
A Final Note: Thank You, Medica 2025
We want to thank everyone we met — from start-up teams to international partners — for the meaningful discussions, inspiring innovations, and shared interest in improving healthcare through high-quality, compliant devices.
If we didn’t have the chance to connect during the event, we would be happy to continue the conversation, contact us at Kristian@mdsdenmark.dk or schedule a consultation via Book a Meeting.
We look forward to seeing you again at Medica 2026.