Production & Quality System
Medical Device Validation
Medical device manufacturers validate two distinct things that are easy to conflate: the processes and equipment that build the device, and the software used in production and the quality system. Neither is the same as software that is itself a medical device.
Production equipment and process validation
- Automated assembly, welding, bonding and sealing processes
- Injection molding and extrusion process validation
- Sterilization process validation and interfaces
- Packaging and seal integrity validation
- Cleaning and passivation processes
- Test and inspection equipment, including vision systems
- Measurement system analysis and gauge capability
Quality system and production software
Software used in production or in the quality system — eQMS, MES, ERP-driven controls, test data systems, statistical tools, document and training systems — should be validated for its intended use, with the depth of assurance driven by risk to product quality and user safety.
This is a different obligation from the design controls, software lifecycle activities and risk management applied to software that is a device or is embedded in one. Keeping the two scopes clearly separated in your quality system prevents both over-validation and gaps.
Risk management and data integrity
Device manufacturers already operate mature risk management practices. Extending that thinking to computerized systems — what record could be wrong, who would notice, what decision would be affected — usually produces a better assurance plan than importing a pharmaceutical template unchanged.
Validation under the effective QMSR
As of February 2, 2026, FDA's QMSR incorporates ISO 13485:2016 into revised 21 CFR Part 820, alongside FDA-specific requirements. Identify production processes whose outputs cannot be fully verified by subsequent monitoring or measurement and justify validation, monitoring and revalidation controls. Do not equate an ISO certificate with a determination of compliance with all applicable FDA requirements.
Software in manufacturing and the quality management system falls within the scope addressed by FDA's current CSA guidance. Software that is itself a medical device, or part of device functionality, requires a separate assessment of design, lifecycle, risk and applicable submission expectations. Qualification of the manufacturing environment does not establish clinical performance.
Primary references
- FDA — Process Validation: General Principles and Practices
- FDA — Computer Software Assurance for Production and Quality Management System Software
- FDA — 21 CFR Part 11, Electronic Records; Electronic Signatures
- FDA — Data Integrity and Compliance With Drug CGMP
- FDA — General Principles of Software Validation
- FDA — Quality Management System Regulation (QMSR)
Information published on ValidationEngineering.com is educational and informational. It is not legal or regulatory advice and is not a guarantee of regulatory compliance or of any inspection outcome. Organizations remain responsible for their own quality decisions.
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