Do you have a complete quality management system? Can you provide ISO 13485 or BSCI certificates?

We are certified with ISO13485, CE and FDA. Some customers have additionally passed BSCI and SGS factory audits, and we can provide the full report set.

Key points:

1. ISO 13485 - Medical device quality management system certification.

2. CE & FDA - EU and US market certification held in-house.

3. BSCI / SGS audits - Social compliance and quality audit reports available.

4. Full documentation - Complete certificate and audit report package provided.

Send us your audit checklist and we will prepare the matching documentation for review.

Contact us for more details: Send Inquiry