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MedTech Certification Support
This regulatory service line is designed to help medical device developers, whether working on physical devices or Software as Medical Device (SaMD), navigate the increasingly complex path to certification. Our offering combines ClinSearch’s clinical and scientific expertise with the insider regulatory knowledge of QUALICOM Ltd (Led by David Francis, former Head of a notified body, with over 25 years of experience in regulatory affairs and medical device certification). This unique blend ensures faster, smarter, and more reliable market access, grounded in operational know-how and hands-on regulatory insight.
MedTech certification is designed for all medical device developers, from early-stage startups preparing their first CE marking, to established manufacturers navigating evolving regulations. We provide end-to-end support at every stage of the certification journey, effectively de-risking your route to market.
With a flexible offering tailored to each project's stage and scale, we deliver a strategic certification approach designed to meet our client’s needs. This includes:
- Comprehensive support – regulatory, clinical, methodologic, and scientific expertise
- Accelerated documentation – faster preparation of technical and clinical files
- Stronger notified body alignment – improved communication and positioning
- Strategic clarity – guided decision-making in an evolving regulatory landscape
Contact us today for an initial evaluation or to learn more about how we can help you achieve your certification objectives.
Our solutions
Selection of and liaison with notified bodies
Classification reports
Route-to-market plans/reports
Clinical strategy reviews
Risk management (risk analysis, plans, reports)
Clinical evaluation plans
Study documents writing
Setting up and managing studies in an international setting
Clinical evaluation reports
PMS/PMCF plans & reports
Technical documentation construction & gap analyses
Liaison with competent authorities
Adverse event evaluation and reporting
Due diligence reports
Technical documentation audits
Our resources
Senior clinical operations director
Regulatory affairs director
Regulatory experts
Project leaders
Scientific & medical advisors
Medical writers
Clinical safety officers