Quality Services
Good Manufacturing Practice compliance is the baseline requirement for every medical device manufacturer operating under FDA oversight. Whether you are preparing for a first FDA inspection, responding to a warning letter, or pursuing ISO 13485 certification, GMP readiness requires systematic preparation — not a last-minute document assembly.
Prepare Your FacilityGMP Readiness
The FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016 both establish QMS requirements for medical device manufacturers, but they are not identical frameworks. ISO 13485:2016 has requirements that go beyond 21 CFR Part 820 in several areas — particularly risk management integration throughout the QMS, customer-related processes, design and development planning, and documented infrastructure requirements for work environments. Conversely, 21 CFR Part 820 is the legally enforceable standard for FDA inspections of US manufacturers and importers, regardless of whether the company holds an ISO 13485 certificate.
Companies that hold an ISO 13485 certificate should understand that the certificate does not guarantee FDA GMP compliance. FDA investigators conduct inspections against 21 CFR Part 820, not against ISO 13485. There are documented cases of companies with current ISO 13485 certificates receiving 483 observations and warning letters during FDA inspections. The overlap is significant but not complete, and preparation for each requires knowledge of the specific requirements of each framework.
FDA may conduct a Pre-Approval Inspection (PAI) before approving a PMA application or granting a De Novo designation to verify that the manufacturing facility can produce the device in accordance with the design and the quality system. PAIs are more focused than routine surveillance inspections — the inspector arrives with the PMA application in hand and will specifically verify that the manufacturing processes and quality system described in the submission match the actual facility operations. Discrepancies between the submission and the facility are the most common finding in PAIs.
Preparation for a PAI requires alignment between the PMA manufacturing information, the QMS procedures, and the actual production operations. We conduct PAI readiness assessments that compare the manufacturing information in the PMA to the current state of the facility, identify gaps, and develop remediation plans that close those gaps before FDA arrives. The preparation timeline for a PAI readiness program is typically 3–6 months before the expected inspection date.
For companies selling into the EU, Health Canada, Brazil (ANVISA), Japan (PMDA), or Australia (TGA), GMP certification may be required as part of market access. ISO 13485 certification from an accredited registrar is the most widely accepted GMP certification mechanism for international markets. Certification audits evaluate the QMS against the ISO 13485 standard in a two-stage process: a document review (Stage 1) followed by an on-site facility audit (Stage 2). Nonconformities found during certification audits must be addressed before certification is granted or maintained.
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GMP compliance is not a document status — it is an operational reality. We prepare facilities for FDA and notified body inspections based on what investigators actually look for, not what the checklist says.