Looking for Partnerships with QM & Regulatory Experts in MedTech

bolts&bytes engineering is an independent engineering consultancy specializing in MedTech and precision engineering.

I am typically brought in when MedTech companies face technical challenges within CAPA, PMS, or product-related issues. I. e. situations where regulatory compliance alone is not enough, and the underlying technical root cause must be identified and resolved.

In my experience, MedTech companies struggle at this interface:
They need to stay regulatorily compliant while also developing a robust technical solution.

With 10+ years of experience in MedTech R&D, I focus on simulation-driven product development in regulated environments (ISO 13485, MDR). Thus, my contribution could be:

• Technical troubleshooting & failure analysis

• Simulation (FEM/CAE) for root-cause identification and design optimization

• Supporting critical technical decisions in complex projects

• Feasibility studies and structured re-design

What I’m looking for:
Partnerships with QM, Regulatory Affairs, or strategy consultancies to:

• Offer integrated technical + regulatory solutions to clients

• Collaborate on CAPA / PMS / product remediation cases

• Refer and complement each other’s expertise in a targeted way

If you work with MedTech clients and are looking for a reliable technical partner for complex problem-solving, I’d be glad to connect.