| Regulatory and Quality Standards |
ISO 14971:2007(E), Application of Risk Management to Medical Devices
ISO 13485:2003, Medical Device Quality Management Systems
ISO 10993, Biological Evaluation of Medical Devices
FDA code of federal regulations, Title 21, Subchapter H, part 820, Quality System Regulation (21 CFR Part 820), also known as current Good Manufacturing Practices (cGMP)
ISO 9001:2008, QMS for the design, development, and delivery of product or service
USP Class I-VI Biological Reactivity Testing
FDA Rule 21CFR177, Indirect Food Additives by Polymer
EC 1907/ 2006 REACH, Registration, Evaluation, Authorization, and Restriction of Chemical Substances
EC 95/ 2002 RoHS, Restriction of Hazardous Substances
|
| Regulatory and Quality Processes and Services |
FDA and CE Medical Device Classifications
FDA Marketing Application Requirements (510(k) and PMA)
Risk Assessments
Control Plans, PFMEAs, and DFMEAs
Packaging Requirements
Sterilization Options and Impact
IQ, OQ, and PQ Validations
Statistical Process Control and Data Management
Measurement Services
Material Characterization and Testing Services
Chemical Compatibility
|
