MEDICAL DEVICE, ivd & ukrp

quality & regulatory consultanCY

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

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.

UK Responsible Person

As of 1st January 2021, non-UK based manufacturers are legally required to appoint a UK Responsible Person (UK RP) to act on their behalf with UK Regulators in order to place their devices on the market here in the UK.

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

"SureScreen Diagnostics worked closely with IMed in the process of gaining an Exceptional Use Authorisation from the MHRA for the SureScreen SARS-CoV-2 Rapid Antigen Test Cassette.  This involved pulling together and evaluating numerous data sets from Usability and Clinical Evaluation Studies, alongside optimising the technical file and Instructions For Use for the self-test device.

‘IMed have a great team who are very knowledgeable about the regulations for IVDs, and we were able to work with them like they were an extension of our own team which worked really well in practice.   They were invaluable in helping us move so quickly to address the market need.The team at IMED were always very helpful, easy to contact, and they went above and beyond to ensure that the process was as smooth as possible and deadlines were met.’

 

David Campbell

Director, Sure Screen Diagnostics Ltd

"The IMed team have helped us, and our global suppliers, to navigate the new regulatory burden and transition from MDD to MDR. They have managed the process throughout presenting workable solutions, enabling us to focus on our key business objectives. I look forward to working with them for our ISO13485 certification and wouldn’t hesitate to recommend the IMed team to deal with any Quality and /or Regulatory need."

John Black

Director, Lawmed Ltd

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!