ISO 13485 Quality Management

What We Do

A Quality Management System shouldn't be a burden. We build right-sized QMS solutions that meet ISO 13485:2016 and FDA QSR (21 CFR Part 820) requirements without slowing you down.

• Gap Analysis: Comprehensive assessment of your current processes against regulatory requirements.
• SOP Development: Custom Standard Operating Procedures tailored to your company size and stage.
• Internal Audits: Independent audits to identify non-conformances before your notified body does.
• Supplier Controls: Robust framework for qualifying and monitoring critical suppliers.