Carmeda fulfills relevant quality standards and regulations to ensure that we meet both customer and regulatory requirements.
Carmeda’s work include design, development, and manufacturing of coating components and performing contract heparin coating services for medical device manufacturers. Carmeda also provides regulatory support to help our customers to reach regulatory approvals and compliance for heparin-coated devices. Quality is a key concept that permeates all Carmeda’s work and is vital to our mission of helping people to a better health by improving the performance of medical devices.
Carmeda’s quality management system meets the requirements of both FDA Quality System Regulation 21 CFR Part 820 and ISO 13485.
Environmental considerations are integrated into the policies that govern our business and the environmental management system fulfills the requirements of ISO 14001.
Carmeda’s in vitro thrombogenicity testing is in accordance with the principles of Good Laboratory Practice (GLP) as established by OECD and the European Community.