Dear Readers,

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.

Enjoy reading!

Best regards,

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
	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
	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”.  Read more
	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. Read more
	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