Industry
Medical device supply chains
Medical device manufacturers must control their suppliers. We provide on-site audits and inspection of Turkish component and device suppliers.
01Supplier control is a regulatory obligation
Under ISO 13485 and medical device regulations, manufacturers must evaluate, select and monitor suppliers according to risk. Typical supplied products include machined and moulded components, assemblies, packaging and sterilisation services.
QUALITAS TR performs supplier audits structured on ISO 13485, reviews process validation and inspects components.
02Typical quality risks we see
- Process validation missing for special processes
- Cleanliness and contamination control
- Change control without notification
- Traceability gaps
- Document control weaknesses
03How QUALITAS TR supports medical devices buyers
| Service | What we do in this sector |
|---|---|
| Quality Management System Audits | ISO 13485 based supplier audits. |
| Manufacturing and Special Process Audits | Validation and process control review. |
| Independent Quality Control | Component inspection. |
04Key inspection points
- Process validation records
- Cleanroom and cleanliness controls
- Traceability
- Change notification
- Inspection records
- Packaging and labelling
05Standards and requirements
ISO 13485 specifies QMS requirements for medical devices. Regulatory requirements depend on the market. QUALITAS TR audits are second-party supplier audits.
06The sector in Turkey
Medical device manufacturing has grown in Ankara, İstanbul, İzmir and Samsun, where a medical device cluster has developed.