We are joining forces with QUALICOM Ltd to enhance our offering for Medical Device Developers looking for certification.
The Evolving Challenges of Medical Device Certification
Bringing a medical device to market has never been more complex. Under MDR or UKCA, the path to certification is long, technical, and filled with regulatory pitfalls. Companies face increasingly rigorous expectations from notified bodies, complex documentation requirements, and heightened scrutiny on clinical evidence et risk management. This is why ClinSearch is raising the bar with a smarter approach to certification.
A New Way Forward: Introducing MedTech Certification Support
We are proud to announce the launch of MedTech Certification Support, a new regulatory service line dedicated to helping développeurs de dispositifs médicaux – whether working on physical devices or Software as Medical Device (SaMD) – navigate the path to certification. Fueled by the alliance between ClinSearch’s extensive clinical et scientifique expertise with the insider regulatory knowledge of Qualicom (Led by David Francis, former Head of approved body), we offer our clients smarter, faster, and more reliable access to marketplus rapide, plus pertinent et plus sécurisé, fondé sur une expertise terrain et hands-on regulatory insight.
MedTech Certification is designed to provide soutien de bout en bout to medical technology innovators through every step of certification, effectively réduire les risques the route to market. Whether you are a startup preparing your first submission or an established manufacturer addressing feedback from regulators, we propose targeted, strategic support, tailored to your needs and challenges.
What We Offer
Nos flexible offering is adapted to each project’s stage and scale, and includes:
- Un accompagnement complet – expertise réglementaire, clinique, méthodologique et scientifique
- Une documentation accélérée – préparation optimisée des dossiers techniques et cliniques
- Stronger Notified Body alignment – positionnement et communication optimisés
- Une stratégie claire – prise de décision guidée dans un environnement réglementaire en constante évolution
Your Trusted Partner in Medical Device Certification
ClinSearch continues to stand beside MedTech innovators, turning complexity into clarity, and challenges into progress.
Ready to move forward? Contactez-nous or visit the MedTech Certification Support site to learn how we can help.
About David Francis, Director of Qualicom
David Francis is a Chartered Engineer and European Engineer with over 25 years of experience in regulatory affairs, engineering, and certification. He has held senior positions at multiple notified bodies and regulatory consultancies, including: LNE-GMED UK (Head of approved body), Scarlet (Certification Lead), ICON plc / MedPass International (Director of Regulatory Affairs), TÜV SÜD, Lloyd’s Register, and BSI Group.
After stepping down from his position as Head of LNE-GMED UK, David founded Qualicom, with the mission of supporting innovation et improving regulatory outcomes for medical device and digital health developers.
From the Inside: A Conversation with David Francis
We sat down with David to better go through the challenges and opportunities facing MedTech innovators today.
Q: David, the regulatory landscape for medical devices has changed dramatically in recent years. What are the biggest challenges you see today under MDR or UKCA?
A: The biggest challenges include limited Notified Bodies causing certification delays, complex documentation requirements, and ongoing regulatory uncertainty, even with extended MDR deadlines. In the UK, manufacturers must prepare for a new conformity assessment process once CE marking recognition ends. The MHRA’s ongoing regulatory revisions add another layer of complexity. Overall, navigating evolving regulations while maintaining market access remains tough for many developers.
Q: Are we past the initial bottlenecks caused by MDR implementation, or do major hurdles remain?
A: While more Notified Bodies are now designated and many manufacturers have transitioned, bottlenecks remain, especially for SMEs and complex devices. Wait times for audits can still be 12–18 months, and many legacy devices risk losing market access if deadlines are missed. High compliance costs and resource demands continue to challenge manufacturers.
Q: What are the most common pitfalls manufacturers face when approaching certification?
A: Common pitfalls include underestimating MDR complexity, misclassifying devices, weak clinical evidence, late engagement with Notified Bodies, incomplete or inconsistent technical documentation, and poor post-market planning. Many also struggle with UDI implementation, labeling compliance, and internal resource constraints. Overall, lacking dedicated regulatory expertise often leads to gaps in compliance planning.
Q: How can this partnership between ClinSearch and Qualicom help MedTech developers navigate these complexities more effectively?
A: Our MedTech Certification Support combines deep regulatory expertise from Qualicom with ClinSearch’s clinical and scientific know-how to add value across your entire product life cycle. From strategic regulatory planning and technical documentation support, to generating robust clinical evidence and post-market surveillance. We help prepare manufacturers for Notified Body engagement and audits, optimize quality management systems, and ensure smoother market access, saving time, costs, and reducing risks.
Q: You’ve worked inside some of the top Notified Bodies. How does that shape your strategic approach?
A: Having worked for a number of major Notified Bodies, I have a strong operational knowledge and understanding of reviewers’ expectations. This insight helps us build robust submissions, anticipate audit triggers, and provide our clients with strategic guidance to reduce surprises and speed up certification.
Q: Any final thoughts for MedTech innovators planning their next move?
A: Start early and be strategic. Align your product, evidence, and documentation with regulatory expectations from day one. Clear, compliant submissions speed reviews and reduce delays. A specialised medical device consultancy can be a critical partner for developers. Partner with experts, especially those who have sat on the other side of the table and know the regulatory system inside out. That knowledge is your competitive advantage.
