QMSR Compliance

The FDA Quality Management System Regulation (QMSR), finalized in February 2024 and effective February 2026, harmonizes 21 CFR Part 820 with ISO 13485:2016. For manufacturers, this means a single QMS can satisfy both FDA and international requirements.

The QMSR transition creates both opportunity and risk. Companies with ISO 13485-aligned QMS systems are well-positioned, but must close gaps in FDA-specific requirements (Design History File, 21 CFR Part 11 electronic records, MDR reporting integration).

Software Quality Guru specializes in QMSR implementation for software-centric medical device companies — particularly those building SaMD (Software as a Medical Device) or hybrid hardware-software products.

A comprehensive QMS gap assessment benchmarks your current quality system against QMSR requirements and identifies risks before an FDA inspection or certification audit.

We assess all QMSR subparts: Management Responsibility, Design Controls (the most common inspection finding area), Document Controls, Purchasing Controls, Production and Process Controls, CAPA, Complaint Handling, Servicing, and Statistical Techniques.

Gap findings are categorized by critical (likely FDA 483 observation or Warning Letter risk), major (audit finding risk), and minor (improvement opportunity) — enabling risk-based remediation prioritization.

Well-written SOPs are the backbone of a defensible QMS. We author and remediate SOPs that are clear, auditor-friendly, and operationally practical — procedures your team will actually follow.

High-priority SOPs we commonly develop: Design Controls (the most critical QMSR procedure), CAPA procedure, Complaint Handling and MDR reporting, Document and Records Control, Supplier Management / Purchasing Controls, and Software Validation procedure.

All SOPs are structured with purpose, scope, responsibilities, procedure steps, and references — formatted for your document management system and version control process.

FDA inspections (Biennial Quality System Inspections or for-cause inspections) can be triggered at any time. Being inspection-ready is not a one-time event — it requires sustained program maintenance.

Our inspection readiness services include: mock FDA inspections with written findings reports, CAPA support for pre-existing 483 observations, back-room support during live FDA inspections, and Warning Letter response drafting.

We also train your team on inspection conduct: how to respond to investigator questions, what documentation to have readily accessible, and how to handle requests for records — reducing the risk of escalation.