Quality and compliance help for Class II and Class III device makers. The FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820) took effect February 2, 2026. It incorporates ISO 13485, and many companies are still closing the gaps.
Gap assessments, then the work to bring design controls, complaint handling, and CAPA in line with the new rule.
Validating production processes and the ERP and quality systems that support them.
If you sell in Europe, your quality system has to satisfy EU MDR or IVDR as well as FDA.
Preparation for FDA, MDSAP, and notified body audits.
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 company's supplier audit schedule has fallen behind. An audit specialist plans and conducts the audits and follows each finding until it is closed.
What do you make, what systems are involved, and what is the problem? We will tell you how we would approach it.