Your strategic partner in medical device development from design to market acces
We turn innovation into approved medical products, by shaping your regulatory strategy through design control, clinical evidence, quality systems and certification.
Support shaped by audit expertise, on both sides of certification.
We’ve witnessed how promising technologies falter when structure is missing, and how they pause when regulatory, clinical and quality strategy are aligned from the outset.
Founded by Adam Isaacs Rae, a UKAS-witnessed, BSI Certified Lead Auditor who has led over 50 ISO 13485 and MDR audits, our approach is built on direct experience working with certification and notified bodies.
We align design, clinical evidence and regulatory strategy early: so when your device is reviewed, it stands up. Fundamentally, we make sure your device has a clinically relevant and visible pathway to market.
How we support medical device organisations
Structured support at every stage of development and compliance.
Medical Device Auditing
Internal audits are mandatory.
Effective audits are rare.
We provide independent ISO 13485 and MDR-focused audits shaped by real certification experience.
Led by a UKAS-witnessed, BSI Certified Lead Auditor with over 50 completed audits, our approach reflects what certification bodies and notified bodies actually examine.
Person Responsible for Regulatory Compliance (PRRC)
PRRC is a legal requirement. Accountability is personal.
We act as your PRRC under MDR and IVDR, providing structured oversight across product conformity, technical documentation and post-market obligations.
Our role keeps responsibility clear, proportionate to your organisation and continuously maintained.
CE Marking & European Market Access Strategy
No certification.
No Market.
We support classification, regulatory pathway planning, technical documentation and Notified Body engagement from the outset.
Our approach helps you reach the EU market deliberately, with systems and evidence built to withstand scrutiny beyond certification.