Process Validation for Medical Devices

When the output of a manufacturing process cannot be fully verified by later inspection or testing, the process itself must be validated. Medfins International plans and executes process validation for medical devices that satisfies ISO 13485, the FDA QMSR, EU MDR notified bodies and CDSCO inspectors.

When is process validation required?

ISO 13485:2016 clause 7.5.6 requires validation of any production or service process whose output cannot be or is not verified by subsequent monitoring or measurement. Typical examples are sterilisation, sealing of sterile barrier packaging, moulding, welding, bonding, coating and cleaning. Clause 7.5.7 adds specific requirements for sterilisation and sterile barrier systems, and clause 4.1.6 requires validation of software used in the quality system.

Our validation approach: IQ, OQ and PQ

1. Validation master plan listing the processes, equipment and software in scope, with risk-based priorities.
2. Installation qualification (IQ) to confirm equipment is installed and calibrated as specified.
3. Operational qualification (OQ) to challenge process limits and establish the operating window.
4. Performance qualification (PQ) to show the process consistently produces conforming product under normal conditions.
5. Statistical sampling and acceptance criteria justified from risk, with a clear rationale reviewers can follow.
6. Revalidation triggers and change control, so validation stays current after process changes.

Processes we validate

• Ethylene oxide sterilisation (ISO 11135) and radiation sterilisation (ISO 11137)
• Sterile barrier and packaging systems (ISO 11607)
• Cleanroom qualification (ISO 14644) and environmental monitoring
• Injection moulding, welding, bonding, coating and cleaning processes
• Quality system software and production software validation
• Test method validation for in-house testing

Common validation findings in audits and inspections

• Processes treated as verified when 100% inspection cannot actually detect the defect.
• OQ studies that never challenge the worst-case process limits.
• Sample sizes with no statistical or risk-based rationale.
• Equipment, materials or software changed without a revalidation assessment.
• Sterilisation and packaging validations that do not cover the full product family or all pack sizes.

We review existing validation files against ISO 13485, the FDA QMSR and EU MDR expectations, and close the gaps before your next audit rather than after a nonconformity.

Validation that supports your approvals

Validation reports are reviewed in ISO 13485 certification audits, MDSAP audits, CE marking technical documentation and FDA inspections under 21 CFR Part 820. We write them so each regulator can trace the requirement, the protocol, the data and the conclusion without further questions.

Ready to start? Book a free consultation with Medfins International or call +91 85270 48221.

Frequently asked questions