The FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820) took effect February 2, 2026. It is built on ISO 13485:2016. Someone with twenty years under the old QSR may still be new to ISO 13485, so we check before we put anyone on your project.
We compare your quality system against the QMSR and ISO 13485 and tell you what needs to change.
Design and development procedures and records that meet the current requirements.
Complaint, CAPA, and post-market processes brought in line with the new regulation.
Getting ready for FDA, MDSAP, and notified body audits.
Help for device companies selling into Europe under EU MDR and IVDR.
A device maker is closing gaps against the QMSR and ISO 13485. Its procedures, design controls, and CAPA process need work. If a new ERP or eQMS is part of the plan, it needs validation help too.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A company's supplier audit schedule has fallen behind. An audit specialist plans and conducts the audits and follows each finding until it is closed.
A QMSR transition project with a fixed timeline. It usually starts with a gap assessment, then moves to procedure updates and audit preparation.
A device quality professional who joins your team to work on procedures, design controls, and CAPA.
Share your situation and the systems involved, and we will outline how we would approach it.