Services

Two doors, and everything around them.

Audits and remediation are what we are known for. These are the other ways we help medical device companies.

Mock FDA, internal, and supplier audits, and quality due diligence.

483 and warning letter response, CAPA, QMS and design history file remediation, and field actions.

Build, fix, or operate the quality system, sized for the company, not over-engineered.

FDA, EU MDR, and global market access strategy, with timelines you can plan around.

Manufacturing readiness, process validation, supplier quality, and design transfer.

Embedded fractional quality and regulatory support for early-stage medtech, from first strategy through first launch.

Tell us what FDA, an auditor, or your own team found. We will tell you how we would handle it.