Company / Quality
Quality Where it Counts
We understand the quality demands of the medical industry. As an ISO ISO13485/9001 registered company, we continue to demonstrate our commitment to excellence. Our products are FDA 510K approved and CE Marked for distribution worldwide. And this is but one of your assurances that our products will meet your expectations.
Strong Quality, Regulatory and Operational Expertise
- PCM products approved by the FDA for a platform 510K
- ISO 13485/9001 Certified
- Highly flexible web accessed PLM systems for all overseas supply chain partners
- All products RoHS compliant for the most stringent EU environmental requirements
- Electronic documentation systems
- Integrated PLM/ERP system (Expandable ERP)
Quality System Certifications:
- PCM Quality System Certified to EN/ISO 13485:2003 and 9001 by TUV
Device Certifications:
- FDA 510K approved, CE marked to MDD 93/42/EEC
- EMC Standard EN 60601-1-2, BF Applied Part, RoHS Compliant
- Safety Standards EN 60601-1, EN60601-2-18 by UL