We offer project management and interim management services to provide a comprehensive solution to the demands and specific business requirements of our clients. Our team offers regulatory affairs services for global markets and supports the full medical device lifecycle from regulatory strategy, clinical evaluation, technical documentation to vigilance and post market follow up.

Regulatory affairs management can be utilised for specific projects and documents to all things EU MDR/IVDR. It can add much needed capacity to your internal team or provide a dedicated resource to plan, schedule and ensure successful delivery that’s tailored to your needs.

What do you need to be compliant?

Medical Device manufacturers need to be complaint with EU MDR/IVDR and the new regulations make more demands than ever before. Manufacturers need to understand the transition from MDD to MDR or IVDD to IVDR and the extra work that is required from them to be compliant.

Several aspects can be utilised for compliance from carrying out a gap assessment to setting up an internal audit or checklist(s).

Manufacturers must also review their Quality Management Systems, implement the new Technical Documentation structure, understand the difference between Essential Requirements and the new General Safety and Performance Requirements, appoint a suitable Person Responsible for Regulatory Compliance, ensure effective Post Market Surveillance is in place and much more to ensure full compliance.

How can Clin-r+ help?

CLIN-r+ has experience in a broad spectrum of clinical specialities which means we have the expertise and know-how to provide the support needed. We tailor the assistance we provide to the individual needs of each client and device, which ensures a personalised service.

Our strategic approach has positive impacts and helps businesses succeed. We can assist with any size project, from undertaking a gap assessment or clinical evaluation to setting up your Technical Documentation structure or a complete MDR transition.

We understand what Notified Bodies expect to see and have a proven track record of enabling our clients to pass audits, gain valuable insights and obtain CE marking. We offer extensive regulatory affairs knowledge and expertise to support your team or undertake complete projects in an efficient and pragmatic way.

CLIN-r+ also provides ongoing maintenance support and we can keep your documentation updated and compliant, creating reports as new data arises and periodically as required.

Need more details?

We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.

You can also check out these white papers on our MedTech Academy:

• Transitioning to the new EU MDR
• EU MDR Readiness Checklist
• New EU MDR Deadlines
• Translating your MDD to MDR submission
• Translating your FDA 510k to an EU MDR submission
• UKCA
• Regulating Medical Devices in the UK
• EUDAMED
• Economic Operators