Regulatory Affairs
• Device master records (DMR)
• Minimum 5-year record retention
• Lot device history records (DHR)
• Complete FDA/cGMP (Current Good Manufacturing
Practices) program
• Lot certification/documentation packets
• Routine documentation releases (RDR)
• 510(k), IDE, PMA consultation
ISO
13485:2003
The
contract manufacture of health care and non- healthcare
products to include production, assembly, packaging and
sterilization where indicated
EN
550:1994
ISO
11135:1994
Ethylene
Oxide
Sterilization for Medical Devices
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