The FDA's foundational GMP standard for Class II and III medical device manufacturers is now evolving into the QMSR. Affinity QMS maps every Part 820 requirement to purpose-built modules so you stay audit-ready from day one.
21 CFR Part 820, the Quality System Regulation (QSR), is the FDA's minimum good manufacturing practice standard for medical devices sold in the United States. It establishes requirements for the methods, facilities, and controls used in designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices.
QMSR Transition — What Changes?
The FDA QMSR replaces the prescriptive, checklist-based Part 820 with performance-based outcomes aligned to ISO 13485:2016. Key changes include an explicit risk management requirement (ISO 14971 integration), updated design control requirements aligned to ISO 13485 Clause 7.3, and strengthened CAPA methodology. Affinity QMS is built to satisfy both legacy Part 820 and the new QMSR in a single configuration.
Key Part 820 Subparts
Subpart B — Quality System Requirements (820.20–820.25)
Subpart C — Design Controls (820.30)
Subpart D — Document Controls (820.40)
Subpart E — Purchasing Controls (820.50)
Subpart G — Production and Process Controls (820.70–820.75)
Subpart I — Nonconforming Product (820.90)
Subpart J — Corrective and Preventive Action (820.100)
Subpart L — Handling, Storage, Distribution (820.140–820.160)
Subpart M — Records (820.180–820.198)
Every Part 820 subpart maps directly to an Affinity QMS module. No manual workarounds. No configuration consulting required.
| Regulation Reference | Requirement | Affinity QMS Module | What It Does |
|---|---|---|---|
| 820.40 | Document Controls | Document Control | SOP version management, controlled distribution, e-signature approval workflows, change control |
| 820.100 | Corrective & Preventive Action | CAPA Management | CAPA initiation, root cause analysis, effectiveness verification, trending, and audit linkage |
| 820.198 | Complaint Files | Complaint Management | Complaint intake, MDR/MDV triage, investigation workflow, adverse event trending |
| 820.30 | Design Controls | DHF / DMR | Design History File and Device Master Record structured to 820.30 requirements; design input/output traceability |
| 820.181 | Device Master Record | DHF / DMR | DMR linking specifications, drawings, production procedures, QA procedures, and labeling |
| 820.22 | Quality Audits | Audit Management | Internal and external audit scheduling, audit plans, findings tracking, CAPA linkage, audit closure |
| 820.25 | Personnel / Training | Training Management | Training records, SOP acknowledgment, competency assessments, training matrix |
| 820.50 | Purchasing Controls | Supplier Management | Approved vendor list, supplier qualification, incoming inspection records, supplier audits |
| 820.90 | Nonconforming Product | Deviations & Nonconformances | NCR initiation, disposition workflow (accept/reject/rework), containment actions, linkage to CAPA |
| 820.70 | Production & Process Controls | Validation Protocol Engine | IQ/OQ/PQ auto-generation for production equipment and software; execution tracking; approval workflows |
Three distinct buyer profiles seek 21 CFR Part 820 solutions. Affinity QMS is purpose-built for all three.
Medtech Startup Founder / VP Regulatory
Building a QMS ahead of a 510(k) or De Novo submission. Needs a compliant, auditable system configured fast — without a six-figure consulting engagement. Looking for software that generates their DHF and validates itself.
QA Director at a Series A–B Device Company
Outgrowing paper-based QMS or an early eQMS that can't scale. Facing an FDA inspection within 12 months. Needs a system that satisfies Part 820/QMSR, links CAPA to complaints, and can survive a QSIT inspection.
Contract Manufacturer or CMO
Servicing multiple OEM clients with different QMS requirements. Needs one neutral, configurable platform that satisfies Part 820 for all clients without forcing process fragmentation. MDSAP consideration is a secondary driver.
21 CFR Part 820 is specific to medical device manufacturers. Explore the verticals and related regulatory frameworks that intersect with Part 820.
Yes. The FDA QMSR (the revised 21 CFR Part 820) became effective February 2, 2026. The legacy Part 820 requirements have been replaced by the QMSR, which incorporates ISO 13485:2016 by reference. Manufacturers must comply with the QMSR — not the legacy Part 820 text — as of the effective date. Affinity QMS is configured to satisfy the QMSR, which also satisfies the substantive requirements of legacy Part 820.
Legacy Part 820 was a prescriptive, checklist-style regulation written in the 1990s. The QMSR replaces the prescriptive requirements with performance-based outcomes aligned to ISO 13485:2016. Key additions in QMSR: (1) explicit risk management requirements incorporating ISO 14971, (2) design controls aligned to ISO 13485 Clause 7.3 including design transfer, (3) updated records requirements, and (4) strengthened CAPA methodology. The practical effect is that ISO 13485-certified manufacturers are well-positioned for QMSR compliance.
Key required records and documents include: Device Master Record (DMR) containing device specifications, manufacturing procedures, and QA procedures; Design History File (DHF) documenting the design process; Device History Record (DHR) documenting each device manufactured; Quality System Record (QSR) containing overall quality system procedures; Complaint files; CAPA records; Audit records; and Training records. Affinity QMS generates and manages all of these in a single, audit-ready system.
FDA inspection frequency depends on device classification and risk level. Class III and high-risk Class II device manufacturers are typically inspected every two years. Class II manufacturers may be inspected every three to five years. Any manufacturer can receive an unannounced for-cause inspection following an MDR report, recall, or complaint trend. First-time manufacturers often receive a Pre-Market Approval (PMA) or 510(k)-related inspection before device clearance. Maintaining a continuously audit-ready QMS is the only reliable strategy.
A Medical Device Report (MDR) is a mandatory adverse event report submitted to the FDA when a device has caused or contributed to a death, serious injury, or malfunction that could cause or contribute to a death or serious injury if it recurs. MDR requirements are governed by 21 CFR Part 803, not Part 820 directly, but your complaint management system (820.198) must support the triage, investigation, and reporting workflow. Affinity QMS Complaint Management includes MDR triage logic and 30-day reporting timeline tracking.
Yes — and this is one of the most common use cases for Affinity QMS. A 510(k) submission does not require a fully operational QMS, but the FDA expects to see evidence of QMS design during the pre-market notification review. More critically, if you receive 510(k) clearance, you must have a compliant QMS in place before you begin commercial distribution. Affinity QMS lets you build your DHF, document your design controls, and establish your CAPA and complaint procedures during the development phase so you are QMS-ready on clearance day.
Yes. The Affinity QMS Validation Protocol Engine auto-generates IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for production equipment, software systems, and processes. These protocols are linked to the relevant Device Master Record and can be executed and approved directly within the platform. No canned validation package purchase, no external consultant required. Your auditor asks for your process validation documentation — you hand it over immediately.
Stop configuring your process around your QMS. Affinity QMS configures to fit your existing workflow — and keeps you audit-ready from day one.