The medical industry is governed by strict regulations on the safety and performance of medical devices, in particular those implanted at a high-risk anatomical site. These regulations are currently undergoing major changes at global level. Addressing the revision of the ISO 5840 series of standards, TÜV SÜD will host a technical conference on the topic of heart valves on 12 June 2017.
To ensure the highest possible uniform level of safety in the medical industry throughout the EU, we need an international standard of quality and safety guidance. Experts from science and industry collaborate in working groups, developing the necessary national and international standards. However, as these standards do not always meet the requirements of the individual regions, some countries – such as the USA – develop their own technical specifications. As the medical device regulation (MDR) comes into effect, the EU Commission now intends to develop its own technical specifications.
At its technical conference on the topic of heart valve prostheses and heart-valve repair and replacement devices, TÜV SÜD will address the key aspects of the revision of the ISO 5840 series. “The conference aims to explain the effects of the new regulation and the different requirements in Europe and the USA, and to point out the challenges faced by the medical device industry. From the patient's point of view, medical devices should be safe and efficient and offer favourable risk-benefit ratios, irrespective of the region where they are used“, explains Dr Bassil Akra, TÜV SÜD.
The conference will be held in English. The main target group comprises heart-valve manufacturers, consultants of medical device manufacturers, clinical research organisations, cardiologists and cardiac surgeons, heart-valve testing laboratories and manufacturers of laboratory testing Equipment.
Interested parties can find further information on our technical conference at www.tuev-sued.de/hvc.
Press-contact: Carolin Eckert