MEDICAL DEVICE & ivd
quality & regulatory consultanCY
HELPING MEDICAL DEVICE AND IN-VITRO DIAGNOSTIC COMPANIES WITH CE MARKING, QUALITY MANAGEMENT SYSTEMS, AUDITING AND GLOBAL REGISTRATIONS.
What we do
CE Marking
Assisting with all aspects of CE Marking including classification, identifying relevant standards, risk management, usability, labeling and compilation of Technical Files and Design Dossiers. Remediation of Notified Body non-conformances.
Quality Systems
Design, implementation, management and auditing of quality management systems to meet regulatory requirements including ISO 13485:2016, FDA 21 CFR Part 820 and MDSAP
MDR / IVDR Transition
Technical documentation and quality systems gap analysis and transition planning. Compilation of Technical Documentation to meet the new requirements.
Global Registrations
Identification of regulatory requirements for global markets along with preparation of submissions for countries such as US – 510(k)’s, Canada, Japan and the Middle East
Clinical Evaluation Reports
Reviewing, updating and writing of Clinical Evaluation Reports to support regulatory requirements and MEDDEV 2.7/1 Rev 4. Providing support for post market surveillance activities.
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
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.”
Let’s Start Something new
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!