**COVID-19 Virus Update: All of our consultants work remotely so it’s business as usual**

MEDICAL DEVICE & ivd

quality & regulatory consultanCY

HELPING MEDICAL DEVICE AND IN-VITRO DIAGNOSTIC COMPANIES WITH CE MARKING, QUALITY MANAGEMENT SYSTEMS, AUDITING AND GLOBAL REGISTRATIONS.

Our Services

Medical Device

CE Marking. Performing gap analysis and compiling technical documentation to enable device and QMS transition to Medical Device Regulation (MDR 2017/745).

In-Vitro Diagnostics (IVD)

CE Marking to Directive 98/79/EC. Performing gap analysis and compiling technical documentation to enable device and QMS transition to IVD Regulation (IVDR 2017/746).

Global Registration

Identification of regulatory requirements for global markets along with preparation of submissions for countries such as US  – 510(k)’s, Canada, Australia, Japan and the Middle East.

Quality Management System

Implementation and maintenance of QMS to ISO 13485, 21 CFR part 820 & MDSAP. Gap Analysis, internal auditing, Management Review, completion of CAPA.

Training

Providing training solutions from basic awareness of quality and regulatory requirements to specific topics helping your teams to get up to speed on compliance.

Resources

Factsheets, Whitepapers, Webinars and other useful links in relation to the IVD and Medical Device industry.

WHAT OUR Clients SAY

“Leeanne has solid experience in quality systems for development and manufacture of sterile medical consumables, and was able to tailor the SOPs and documentation systems to fit our product characteristics and scale.” 

Dave Hampton

Chief Technical Officer, Camstent Ltd

“Without the help and expertise of Leeanne and her team it would have taken us significantly longer to reach our goal, we would recommend IMed Consultancy to anyone needing help in navigating the challenges and pitfalls involved in meeting the current requirements for technical files in medical devices.”

Joe O'Neill

General Manager , GM Instruments Ltd

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Say Hello!

Feel free to get in touch with any questions or enquiries you may have or go the old fashioned route and give us a call on +44(0) 1295 724286.

We would love to hear from you!