Quality and compliance support for Class II and Class III device manufacturers operating under the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820), which took effect February 2, 2026 and incorporates ISO 13485.
Gap assessments, design controls, complaint handling, and CAPA aligned to the current regulation.
Validation of production processes across your quality systems and validated ERP infrastructure.
Quality systems that meet FDA and EU MDR/IVDR requirements.
Preparation for FDA, MDSAP, and notified body audits.
A medical device manufacturer closing gaps against the FDA QMSR and ISO 13485 needs contract quality and compliance support for its procedures, design controls, and CAPA process. If a new ERP or eQMS is involved, the team also needs validation support.
A compliance and audit specialist supports a supplier audit program, planning and conducting audits and driving findings to closure.
Tell us about your organization, regulatory environment, and need. We will scope the engagement against your specific GxP context.