MedTech Integrity was founded by Jack Bacon, a Regulatory Affairs professional with experience across EU MDR, UKCA and FDA environments, including Software as a Medical Device (SaMD) and higher-class devices.

Defensible Regulatory Systems for Scaling MedTech

MedTech Integrity supports medical device and SaMD teams preparing for audit, submission, scale or investment.

In MDR, UKCA and FDA environments, compliance maturity is not measured by document volume, it is measured by structural control.

I work with organisations to ensure their regulatory systems are coherent, traceable and defensible under scrutiny.

Senior QA / RA Oversight

Experience across:

• EU MDR & UKCA

• FDA regulatory environments

• Software as a Medical Device (SaMD)

• ISO 13485 QMS development

• Risk management (ISO 14971)

• PMS & PMCF integration

• Technical documentation & audit readiness

This is leadership level regulatory support focused on system integrity, not template driven consultancy.

Philosophy

Compliance isn’t about more paperwork.

It’s about clarity, consistency and control.

When systems are structurally sound, audit becomes confirmation, not confrontation.

Jack Bacon

Founder | MedTech Integrity