Quality and compliance support for device makers under the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820). It took effect February 2, 2026 and builds on ISO 13485:2016. Experience under the old QSR does not prove fluency with ISO 13485, and we assess for that difference.
Compare your quality system against the QMSR and ISO 13485 and identify what needs to change.
Design and development procedures and records that meet the current requirements.
Complaint, CAPA, and post-market compliance processes aligned to the regulation.
Preparation for FDA, MDSAP, and notified body audits.
Support for device companies working to EU MDR and IVDR requirements.
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 biotech preparing for its first FDA pre-approval inspection needs contract compliance and CSV support, including mock inspections, documentation review, and validated systems and electronic records that meet Part 11 and Annex 11 requirements before the inspection window.
A compliance and audit specialist supports a supplier audit program, planning and conducting audits and driving findings to closure.
A QMSR transition project covering gap assessment, procedure updates, and audit preparation against a fixed timeline.
A medical device quality and compliance professional embedded in your team to support procedures, design controls, and CAPA.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.