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Company Overview

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-market medical devices activities covering the following:

 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