We can guide your company to compliance and certification according to the following standards:
- ISO 9000: 2015 Quality management systems – Requirements for distribution companies. We can also adapt your QS to the applicable part of ISO 13485:2016 regarding medical device trading.
- ISO 13485:2016 - Quality System Standard designed specifically for medical devices. This standard is mandatory for most Class 2a, 2b and 3 medical devices and IVDs in Europe. We offer specific programs for the transition from ISO 13485:2003 to ISO 13485:2016.
- Canadian Medical Devices Regulation
- U.S. FDA Quality System Regulations