Founder’s Note:
I’m Hugo Felix, founder of MedDev QE Solutions. After 25+ years leading quality teams at global organizations like BD, Pfizer, Siemens, and J&J, I launched this firm to bring Fortune 500 compliance clarity to fast-moving MedTech environments.

I know what it takes to pass audits, scale systems, and launch breakthrough devices — because I’ve done it across vascular access, combination products, SaMD, and diagnostics. I've resolved FDA 483s, remediated DHFs at scale, and eliminated a 1,700+ case complaint backlog. Now I help startups, investors, and acquirers do it faster — without building bloated internal teams.

My Mission:
To help MedTech innovators operate with speed and compliance — by building right-sized quality systems and de-risking regulatory exposure before it becomes a blocker.

What You Get:

• Strategic clarity in complex regulatory environments

• Systems that scale from first submission to full commercialization

• A partner who works fast, leaves your team stronger, and measures success by results

Credentials:

• ISO 13485:2016 Lead Auditor (BSI)

• Executive QA leader across BD, Pfizer, J&J, Siemens

• 25+ 510(k)s supported | 100+ design files reviewed | Global audit readiness

Let’s connect and explore how MedDev QE Solutions can support your growth.