Medical Devices · Process Validation
Medical Device Process Validation Consulting
The short answer
Device manufacturers must validate any process whose results cannot be fully verified by subsequent inspection and test. The judgment call — what genuinely requires validation versus verification — is where most programs go wrong, and it is where we usually start.
Why this matters
- Over-validation consumes capacity; under-validation puts product conformity on inspection alone, which is rarely defensible for processes like welding, molding or sterilization.
- OQ challenge conditions that never leave nominal settings do not establish a process window.
- Software used in production or the quality system requires validation for its intended use, and this is a frequently cited gap.
Applicable regulations and standards
- 21 CFR 820.75 / QMSR
- Process validation where results cannot be fully verified by subsequent inspection.
- ISO 13485 clause 7.5.6
- Validation of processes for production and service provision.
- GHTF/SG3 process validation guidance
- Decision framework and IQ/OQ/PQ methodology widely used by industry and auditors.
- ISO 11135 / 11137
- Sterilization validation for ethylene oxide and radiation processes.
What our consultants actually do
- Build the validation decision tree that documents which processes are validated, verified or both
- Write and review IQ, OQ and PQ protocols with challenge conditions that establish an actual process window
- Support sterilization, packaging and seal validation, including aging and distribution simulation
- Validate production and QMS software for intended use, with risk-based test depth
- Define revalidation triggers and connect them to change control
- Remediate legacy validation packages, including inherited processes from acquisitions or contract manufacturers
Across the product lifecycle
01 / DEVELOP
Process capability considered during design, not after design freeze.
02 / SCALE
Tooling, fixtures and automation qualified before production commitment.
03 / TRANSFER
Design transfer evidence that the process can be run in production.
04 / VALIDATE
IQ/OQ/PQ executed with justified sample sizes and challenge conditions.
05 / MANUFACTURE
Monitoring, control charts and nonconforming product handling.
06 / MAINTAIN
Revalidation on change, periodic review and equipment lifecycle.
Problems we are usually called about
- Sample sizes chosen by convention with no confidence and reliability rationale
- OQ run only at nominal parameters, so no proven acceptable range exists
- Contract manufacturer validation accepted without review of the underlying data
- Software validation limited to installation testing
- Change control that does not evaluate validation impact
Typical deliverables
- Validation master plan and process validation decision matrix
- IQ/OQ/PQ protocols with statistical rationale
- Sterilization and packaging validation strategy
- Software validation plans and test records
- Legacy validation gap assessment and remediation sequence
Frequently asked
- Which device processes must be validated?
- Any process whose output cannot be fully verified by subsequent inspection and test — commonly sterilization, sealing, welding, molding, coating, cleaning and many automated assembly steps. The decision should be documented, including for processes you conclude do not require validation.
- How are sample sizes justified?
- Through a stated confidence and reliability basis tied to the risk of the attribute being evaluated, documented in the protocol before execution.
- Do we need to revalidate after moving equipment?
- A relocation should trigger an assessment through change control. In most cases at least installation qualification is repeated, with operational or performance qualification scoped by risk.
References
More for medical devices
QMSR, ISO 13485 and device manufacturing quality support.
- QMSR TransitionThe Quality Management System Regulation incorporates ISO 13485 into FDA's device quality system requirements.
- ISO 13485ISO 13485 defines a quality management system for organizations involved in the medical device lifecycle.
- CAPACAPA is the system FDA examines first in a device quality system, because it reveals whether the organization detects and fixes its own problems.
- Supplier QualityPurchasing controls make you responsible for the quality of what others make for you.
- 510(k) Quality SupportThis page is about the part of a 510(k) that lives inside your quality system: the design history file, process and sterilization validation, supplier controls and the manufacturing description.
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