International: Key differences in ISO 13485:2016

The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others relate to the overall approach to quality management systems for device companies. Emergo Group has prepared a short video that describes six key differences between ISO 13485:2003 and ISO 13485:2016.

To watch the video please click here.

• ATTENTION: fake certificates!
• International: Key differences in ISO 13485:2016
• USA: FDA updates list of recognized standards
• EU: (Re-)Designation process for notified bodies means bottleneck for medical devices manufacturers
• India: Consultation on Essential Principles for Medical Devices
• MEDCERT obtains accreditation for DIN EN ISO 13485:2016
• International: Consulting companies
• USA: MEDCERT-USA, LLC at the RAPS Regulatory Convergence in DC Waterfront