Validation
Any process whose output cannot be fully verified afterwards must be validated (ISO 13485 clause 7.5.6). Validation records are among the first things auditors ask for, and weak acceptance criteria are among the most common findings. We help you get protocols right the first time.
Sterilization validation
Strategy, protocol and report review for ethylene oxide (ISO 11135) and radiation (ISO 11137) sterilization, coordinated with your contract sterilizer.
Test method validation
Validation of QC test methods for release, incoming and performance testing, with justified acceptance criteria.
Cleanroom and environment
Cleanroom classification and monitoring requirements under ISO 14644, linked to your contamination control approach.
Process validation review
Independent review of IQ/OQ/PQ protocols and reports against ISO 13485 and your risk analysis.
FAQ
Which processes require validation?
Processes whose output cannot be fully verified by later inspection or testing, for example sterilization, sterile barrier sealing, bonding or welding. A process risk assessment is the most robust way to document the decision.
Other services
Remote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
QMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
EU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
Supplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
CAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.