In this issue, we would like to share with you some valuable insights and information from our practical experience. In “How to Design Safe Medical Products” we deal with the optimization of the development process. In addition, we would like to inform you on the current status of the consultation on the new Europe-wide IVD regulation, on Risk Management Standard EN ISO 14971:2012, and on additional audits for ARTG registration in Australia.
Dr. Peter Havel
Senior Vice President, Medical & Health Services Global
New IVD regulation slowly making progress
A new in-vitro diagnostic regulation is currently in progress as part of the revision of European Medical Device legislation. Read more
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How to design safe medical products
“How to Design Safe Medical Products”, an article appearing in the July issue of the American industry magazine “Machine Design”, is worth reading. Read more
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Risk management standard EN ISO 14971:2012
The Notified Body Recommendation Group (NBRG) published the draft “Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012”.
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Leading researcher visits TÜV SÜD Scientific Advisory Board
At the invitation of the TÜV SÜD Scientific Advisory Board for Medical Devices, Munich heart surgeon Professor Dr. Dr. Bruno Reichart visited the company to speak on innovations in transplant medicine.
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Increased audits for ARTG registration
The Australian Therapeutic Goods Administration (TGA) will, as a rule, be carrying out audits of applications for registration in the Australian Register of Therapeutic Goods (ARTG) in which certain Notified Bodies have been involved. Read more
MDSAP: Start of the first audits
TÜV SÜD America is one of the first Auditing Organizations (AO), which, beginning July 2014, has been authorized by the International Medical Device Regulators Forum (IMDRF) to carry out audits within the MDSAP pilot program. Read more