Quality is Our Foundation
At PCM, We understand the regulatory and quality requirements of the medical environment. As an ISO ISO13485/9001 registered company, we continue to regularly demonstrate our commitment to excellence. Our products are FDA 510K cleared and CE marked for worldwide distribution. This is but one of the assurances that our products will meet the expectations of our customers.
- All products FDA 510(k) cleared, CE marked to MDD 93/42/EEC
- ISO 13485/9001 Certified
- PCM Quality System Certified to EN/ISO 13485:2003 and 9001 by TUV
- EMC Standard EN 60601-1-2, BF Applied Part, RoHS Compliant
- Safety Standards EN 60601-1, EN60601-2-18 by UL
- Highly flexible web accessed PLM systems for all supply chain partners
- All products RoHS compliant, the most stringent EU environmental requirement
- Internal electronic documentation systems
- Integrated PLM/ERP system