ISO 13485 Quality Management System
ISO 13485:2016 is now the common language of medical device regulators: the EU MDR expects it, the FDA QMSR incorporates it, and Gulf regulators such as SFDA require it for marketing authorization. We build one lean system that serves all of your markets instead of a patchwork per country.
Implementation
Gap analysis, process map, quality manual, procedures and record templates, sized to your company and devices.
Multi-market upgrade
Extending an existing system for MDR, QMSR or SFDA requirements without duplicating procedures.
Risk management integration
ISO 14971 risk management linked to design, production, complaints and CAPA, not kept in a separate binder.
Training
Role-based training for management, QA/RA and production staff, focused on application rather than clause memorization.
FAQ
How long does ISO 13485 implementation take?
Typically several months, depending on company size, device risk and what already exists. Before a certification audit, at least one full internal audit cycle and a management review should be completed.
We have ISO 9001. Is that enough?
No. ISO 13485 adds device-specific requirements such as risk management, design controls, sterile product requirements, traceability and regulatory reporting. An ISO 9001 system is a good starting point.
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.
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.
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.