CAPA & Quality Processes
CAPA and complaint handling are where FDA investigators and notified body auditors most often find problems, because these processes live on the shop floor, not on paper. We set up processes that work, can be measured and that your team actually uses.
CAPA
Root cause analysis, corrective and preventive action workflow, effectiveness checks and trending.
Nonconformance
Identification, segregation, evaluation and disposition of nonconforming product, linked to CAPA.
Complaint handling
Intake, investigation and reportability assessment, feeding risk management and post-market surveillance.
Document control
Document lifecycle, revision and approval workflow, record retention; support moving to an eQMS.
Batch records and release
Device history / batch record review and a product release process that holds up in an audit.
FAQ
Does every nonconformance need a CAPA?
No. One-off, low-risk nonconformances can be closed with a correction. CAPA is for recurring, systemic or high-risk issues, and the criteria should be defined in your procedure.
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.
Validation
Sterilization validation, test method validation, cleanroom and process validation reviews.
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.