One discipline. Whichever inspector you answer to.

FDA investigators under the QMSR (Quality Management System Regulation) — and, if you sell into Europe, your notified body under ISO 13485.

A design history file that tells one complete story, CAPA that closes with evidence rather than intent, and supplier controls you can demonstrate on the day.

A gap assessment against the QMSR and 13485, a remediation plan ranked by inspection risk rather than by effort, and a mock inspection run the way the FDA runs one.

FDA investigators under 21 CFR 210 and 211, alongside partner and customer audits that often arrive first.

Batch records that reconcile, data integrity provable end to end, and change control that was followed — not merely written.

Supplier and internal audits, a data-integrity assessment across your critical systems, and 483 responses that commit only to what you can actually deliver.

The FDA — first at your clinical sites under GCP, later at manufacturing under GMP. The second visit judges decisions you made before the first.

A quality system that grew with the company, rather than one assembled in the quarter before the inspection.

A QMS sized for the stage you are at now, built so the commercial-scale version is an extension of it instead of a rebuild.

The FDA for the device itself; CLIA and CAP for the laboratory running it. Two regimes, one operation.

Validation that matches the claim being made, and a laboratory whose competence is documented as carefully as its results.

Audits scoped to CAP/CLIA, method-validation review, and quality-system work that covers the device and the lab as one thing.

The FDA, applying both device and drug expectations to a single product under 21 CFR Part 4.

One coherent quality system — not two systems bolted together at the seam where the constituent parts meet.

A streamlined-approach assessment under Part 4, and the design-control to cGMP mapping that makes a single system defensible.