Engineering safe, compliant devices — from concept to commercial.
ISO 13485 and FDA-aligned engineering, quality, and regulatory talent.
Medical device organizations must move fast while meeting ISO 13485 and FDA 21 CFR Part 820 requirements. Proximate delivers quality, regulatory, and product engineering talent backed by design-controls and digital tooling expertise.
Where we add leverage.
Design controls
Maintaining DHF, DMR, and DHR integrity across rapid iteration.
510(k) and PMA submissions
Preparing global submissions while managing post-market changes.
Risk management
ISO 14971 hazard analysis embedded in development.
Scale-up rigor
Process and test method validation that holds under audit.
Capabilities.
- 01Design Controls, CAPA, and Risk Management programs
- 02510(k), PMA, De Novo, and EU MDR submissions
- 03Process, test method, and software validation
- 04Mechanical, electrical, and firmware product engineering
- 05Quality engineering and supplier qualification
By the numbers.
Explore further.
Information Technology
Software, cloud, data, and DevOps for digital-first enterprises.
Learn more →Life Sciences
Pharma & biotech engineering and talent under GMP and FDA rigor.
Learn more →Manufacturing & Engineering
Automation, controls, and process engineering for modern manufacturing.
Learn more →Solve a medical devices challenge.
Engineering services and specialist talent — one partner.