Your

MedTech

Compliance

Experts

Expert RA/QA Support. Response within 24 hours, even on weekends.

Book a free consultation
A modern, open-concept workspace filled with natural light and greenery, reflecting the clean and organized design of Nimbus Library.
About us

Why MedTech Start-ups and SMEs Choose MD Compliance

We combine the speed and flexibility of a small firm with the deep expertise of global consultancies.

Flexibility
Scalable engagements that adapt to your stage and needs.
Deep Expertise
Senior consultants with MDR, IVDR, QMS and FDA experience.
Fast Response
Personalised support within 24 hours, even on weekends.
Learn more
Two Nimbus Library founders in a minimalist office, showcasing the professional and versatile use of the library.
our services

Comprehensive Regulatory & Quality Solutions

Icon Design

Training & Staff Augmentation

On-demand regulatory expertise, workshops, and outsourcing support.
Icon Design

Quality Management Systems

ISO 13485, Internal Audits, CAPA, MDSAP, and supplier audits.
Icon Design

Regulatory Affairs

MDR, IVDR, Clinical Evaluation, FDA submissions, and more.
Our team

Meet Our Senior Consultants

Portrait of James Parker

Richard Love

Managing Director & Senior Consultant
30+ years in MedTech in both industry and consulting
Portrait of James Parker

Richard Vincins

Director of Regulatory & Quality
30+ years MedTech veteran with significant FDA & EU MDR/IVDR experience
Portrait of James Parker

Brian Goemans

Senior Regulatory Consultant
Regulatory specialist and Biomedical Engineer with a background in software and SaMD
See full team
Resources

Check out our recent insights & case studies

View all resources
Articles

Regulatory Challenges In the EU for start-ups and SMEs

March 5, 2026
Two women in professional attire, illustrating the concept of following fashion trends for 2025.
Articles

We Plan to Submit a 510(k) and There Are So Many Similar Devices on the Market - How Do We Choose a Predicate Device?

February 24, 2026
Two women in professional attire, illustrating the concept of following fashion trends for 2025.
Articles

How To Handle a FDA Inspection and Reduce Form 483 Risk

February 24, 2026
Two women in professional attire, illustrating the concept of following fashion trends for 2025.
Two Nimbus Library founders in a minimalist office, showcasing the professional and versatile use of the library.

Need Regulatory or Quality Support?

Our consultants respond within 24 hours. Let’s talk.
Book a free consultation
Brand Logo Nimbus Library
A specialist MedTech consultancy offering expert guidance in Regulatory Affairs and Quality Assurance.
Book a free consultation