Expertise
Medical Device Quality & QMSR
The Quality Management System Regulation aligns FDA requirements with ISO 13485, but alignment on paper is not the same as an operating quality system. We help device manufacturers assess what genuinely changes for them and implement it without disrupting production.
Device quality system support
- QMSR transition assessment and implementation planning
- ISO 13485 alignment for organizations coming from 21 CFR Part 820
- Design control, design history file and design transfer support
- Risk management integration consistent with ISO 14971
- Production and process controls, device master record and device history record
- Complaint handling, MDR decision-making and post-market surveillance
- CAPA, nonconforming product and supplier controls
- Process, software and sterilization validation support
For device manufacturers of any size
We support single-product startups preparing for their first quality system as well as established manufacturers harmonizing multiple sites. Our consultants include former FDA device investigators, so guidance reflects how requirements are actually evaluated during an inspection rather than only how they read.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.