The medical device market changes frequently in terms of technology, risk potential, marketing and reimbursement. Therefore, it is imperative for clients to engage regulatory professionals who are aware of existing requirements and new developments in the global market.
At Chris Freer Associates Limited we have a team of motivated Senior Regulatory professionals with proven organisation, strategic and communication skills, who adopt a logical and methodical approach to problem solving, achieving tasks and objectives. Including a wealth of experience and knowledge built on a strong manufacturing background in the Medical Devices and Pharmaceutical industry.
Providing freelance consultancy which is tailored to our clients’ requirements and provided either onsite or remotely. Our clients come from all backgrounds and all sizes and from a wide range of different therapeutic areas.
We specialise in pre & post-
Regulatory Strategy Development (worldwide)
Regulatory Market Requirements and Market Intelligence
CE Marking Process
Technical File & Product Design Dossier Development
Medical Device Directive Compliance Reviews and Strategy
Labelling Reviews and Strategy
Own Brand Labelling Strategy
Medical Device Regulations (Replacement for MDD) Gap Analysis, Integration and Transformation Reviews and Strategy
QMS Reviews and Strategy
Risk Management Reviews and Strategy
Design Control Reviews and Strategy
Clinical Investigation Plan and Reports
Competent Authority and Notified Body Liaison Meetings
510k Reviews and Strategy
Combination/Borderline products and CMC Integration Projects