Quality & Compliance Practice

What This Practice Does

The Quality & Compliance Practice performs QMSR (21 CFR Part 820) and ISO 13485:2016 gap assessments, prepares responses to FDA Form 483 observations and Warning Letters, and runs the three-part procedure, forms, and records audit that most quality systems eventually need: a clause-by-clause procedure review, a records-request sampling pass, and a records-level audit against those same procedures. The practice also covers design controls, CAPA process design and oversight, supplier controls, and the initial importer and distributor obligations that apply to companies bringing devices into U.S. commerce without manufacturing them directly, plus MDR and complaint-file management.

How the Work Is Run

A quality engagement typically opens with a documentation review — quality manual, SOPs, and forms — scored against the applicable standard and classified by severity, so a client can see at a glance what's a paperwork gap and what's a substantive compliance risk. Where records-level sampling is in scope, the practice pulls CAPAs, complaints, nonconformances, training records, supplier files, and device history records to confirm the system works in practice, not just on paper. For 483 and Warning Letter response work, the practice director is the one drafting the FDA-facing response and the CAPA strategy behind it — not a junior reviewer working from a template.

Device Areas This Practice Serves

Quality & Compliance supports every device-area group with the same procedure-and-records discipline. For surgical, orthopedic, and ENT instruments, the practice frequently works alongside the Regulatory Submissions practice on reprocessing validation and initial importer obligations for contract-manufactured devices. For cardiovascular devices and digital health and SaMD, the practice's design-control and CAPA work is coordinated with the relevant clinical or software practice so quality findings and regulatory strategy stay aligned rather than working at cross purposes.

Typical Engagement Flow

A quality engagement typically opens with the Stage 1 documentation review, producing a severity-classified gap report and corrective action matrix the client can act on immediately. Where records-level sampling is in scope, Stage 2 follows with CAPA, complaint, nonconformance, training, supplier, and device-history-record sampling to confirm the system holds up in practice, not just on paper. For urgent 483 or Warning Letter situations, the practice director moves directly to drafting a structured CAPA strategy and FDA response, often on a compressed timeline measured in days rather than weeks.

Why a Single Director of Record Matters

A 483 response or Warning Letter remediation plan is judged by FDA on whether the corrective action actually closes the observation — not on whether the response document reads well. That judgment call, about what level of CAPA is proportionate to a given observation and whether a quality-system fix is durable or cosmetic, is exactly the kind of decision that degrades when it's made by whoever is available that week rather than the director who has been inside the quality system from the gap assessment forward. This practice keeps that judgment with one accountable director for the life of the engagement — which matters most when a remediation plan spans several quarters and FDA expects to see the same program logic reflected consistently from the first response letter through the follow-up verification it requests.

Who Leads It

Practice Director, Quality & Compliance. Your practice director is named in the proposal and statement of work.