FDA Quality Management System Regulation (QMSR)
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)

FDA Quality Management System Regulation (QMSR) QMSR-ISO13485-Sec7_DesignControls: Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)

ISO 13485:2016 clause 7.3 (Design and development), which the QMSR incorporates through §820.10 and which carries the medical-device design controls. (7.3.1) GENERAL - a documented design and development procedure; (7.3.2) PLANNING - planned and documented stages, reviews, verification, validation and transfer activities, responsibilities, traceability and resources, updated as the work progresses; (7.3.3) INPUTS - functional, performance, usability and safety needs for the intended use, applicable regulatory requirements and standards, risk-management outputs, information from earlier similar designs and other essential needs, reviewed for adequacy and approved; (7.3.4) OUTPUTS - in a form that can be verified against the inputs, approved before release, giving what purchasing, production and service need and the product acceptance criteria; (7.3.5) REVIEW - systematic reviews at planned stages involving the functions concerned, with records; (7.3.6) VERIFICATION - to documented plans with methods, acceptance criteria and a sample-size rationale, confirming outputs meet inputs, including when the device is connected to other devices; (7.3.7) VALIDATION - to documented plans on representative product (initial production units, batches or equivalents), including clinical or performance evaluation where regulations call for it, finished before release to the customer; (7.3.8) TRANSFER - documented procedures confirming outputs are suitable for manufacturing before they become final production specifications; (7.3.9) CONTROL OF CHANGES - changes identified, their significance assessed, then reviewed, verified, validated as appropriate and approved before implementation, with records; (7.3.10) DESIGN AND DEVELOPMENT FILE - kept for each device type or family, holding or referencing the records of conformity and of changes. The QMSR no longer uses the former QSR term design history file (DHF); the 7.3.10 file carries that content.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 23 controls across 11 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Aged Care Quality Standards 2019 (repealed edition) · 3 controls

  • ACQS-3-1 Safe and Effective Care
  • ACQS-8-2 Clinical Governance
  • ACQS-8-4 Risk Management

HITECH Act · 3 controls

  • HITECH-Coord-HIPAA-Privacy-Security-Cures-ONC HITECH Coordination with HIPAA Privacy Rule + HIPAA Security Rule (Verified Separately) + 21st Century Cures Act + ONC
  • HITECH-Enforcement-CMP-Tiers-StateAGs-OCR HITECH 4-Tier Civil Monetary Penalty Structure, State AGs Enforcement and HHS OCR Settlements
  • HITECH-SubtitleD-Breach-Notification-BA-Direct-Liability HITECH Subtitle D - Breach Notification Rule (45 CFR Part 164 Subpart D), Business Associate Direct Liability, Subcontractors

ICH E6(R3) - Good Clinical Practice · 3 controls

Regulation on the European Health Data Space (EHDS) · 3 controls

  • EHDSREG-1 Mandatory Requirements for EHR Systems (Articles 14-29)
  • EHDSREG-3 Secondary Use - Health Data for Research and Innovation
  • EHDSREG-5 Cross-Border Health Data Flows

COSO Internal Control - Integrated Framework (2013) · 2 controls

  • CA-10 Selects and Develops Control Activities
  • CA-12 Deploys Through Policies and Procedures

Florida Digital Bill of Rights (FDBR) · 2 controls

  • FDBR-704 Exemptions (§501.704)
  • FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)

TEFCA - Trusted Exchange Framework and Common Agreement · 2 controls

  • TEFCAREC-1 Common Agreement Conformance and Onboarding
  • TEFCAREC-2 Privacy, Security, Minimum Necessary

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) · 1 control

  • IVDR-Art.56_57_58 Performance evaluation, performance studies and additional requirements (Articles 56-58)

EU Medical Devices Regulation (MDR 2017/745) · 1 control

  • MDR-Art.61_62 Clinical evaluation and clinical investigations general requirements (Articles 61-62)

GAMP 5 - Good Automated Manufacturing Practice · 1 control

  • GAMP5-Risk-CriticalThinking Risk-Based Approach, Critical Thinking and 5 Key Concepts

IEC 60601-1 - Medical Electrical Equipment Safety · 1 control

  • 60601-1.12 Accuracy of controls and instruments

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)

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The graph holds this control, the 23 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll FDA Quality Management System Regulation (QMSR) controls