**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 Devices
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.”
“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.”
Get in touch to find out how we can work together
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!