E-ssentials medical devices, Edition 1, January 2016
Do you sometimes wish you could see into the future? Given the current situation in Europe and worldwide, I often find myself wondering what the New Year will bring.
When it comes to medical devices, TÜV SÜD can give you some idea of what lies ahead that include an up-to-date understanding of "Functional Safety", the new IEC 62366-1:2015 on usability processes, key changes in IEC 62304 “Medical Device Software – Software Life Cycle Processes“ with amendment 1:2015, and Canada’s transition to the Medical Device Single Audit Program (MDSAP).
In 2016 medical device manufacturers will again be forced to respond to a host of far-reaching changes. Fortunately, these changes are more predictable than world politics and allow us to make early adjustments.
Whether predictable or unpredictable, I wish you a sure hand throughout all the challenges 2016 may bring.
Have a healthy and happy New Year!
Dr Peter Havel Senior Vice President, Medical & Health Services Global
The qualifications and certifications it awards to persons in the field of health satisfy the highest quality requirements and are renowned throughout the world. We offer the following seminars for medical device manufacturers.