Why get ISO 13485 certified in Iraq?
- Meet regulatory expectations for medical device quality
- Support registration with health authorities
- Control design, risk management and traceability
- Increase confidence of hospitals and distributors
Who it is for
Medical device manufacturers, importers, distributors, sterilisation services and maintenance providers.
Key requirements
- Risk-based QMS with regulatory requirements
- Design and development controls
- Traceability, sterility and cleanliness controls
- Complaint handling and advisory notices
How GCQM delivers certification ISO 13485
GCQM is the exclusive agent in Iraq of Global Quality Certification Ltd (GQCL), accredited by EGAC (IAF / ILAC MRA signatory). Our Baghdad team manages your application, plans the audit and provides local auditors, while GQCL takes the impartial decision and issues the certificate, verifiable on its public register.
About our Certification service