Clinical & Regulatory Support for Medical Device Companies
We support MedTech startups and manufacturers with clinical evaluation and regulatory compliance activities, helping teams navigate complex requirements with clarity and confidence.
Regulatory & Clinical Strategy Support
We work with you to understand your device, intended use, and regulatory context, and to define an appropriate clinical and regulatory approach aligned with applicable requirements.
Clinical Evaluation Activities
Support across clinical evaluation planning, literature review, and documentation activities, in line with MDR and relevant MDCG guidance.
Post-Market & Lifecycle Support
Ongoing support for post-market clinical follow-up, updates, and regulatory maintenance activities as your device and organisation evolve.
Trusted MedTech Compliance Support
Experienced Support You Can Rely On
Medical device compliance requires careful interpretation of evolving regulations and guidance. We provide experienced, pragmatic support to help teams approach clinical and regulatory requirements in a structured and informed way.
We work collaboratively with your internal teams, offering clear explanations, practical input, and ongoing support throughout your compliance journey.
Why Work With MedTechCompliance
Focused exclusively on medical devices Experience across MDR and clinical evaluation activities Clear, structured, and pragmatic approach Flexible support tailored to your organisation’s needs Transparent communication and realistic expectations
