New laws, new regulations, new standards – in this issue, we once again report on three topics that illustrate the vast number of changes in the regulatory landscape to which industry must constantly react and adapt. With so much reading material, you may find the new video clips in our newsletter a welcome change. We want to make it easy for you to stay up-to-date on the approval of medical devices and are eager to hear how you like our “E-ssential Clips”. Let me know! I look forward to your feedback.
Dr Peter Havel Senior Vice President Medical & Health Services Global
ISO 13485:2016 with new requirements
The new ISO 13485:2016 edition of the standard builds on the ISO 9001:2008 standard and includes additional regulatory requirements for manufacturers and service providers.