Certification for certification bodies The international ISO/IEC 17065:2012 standard establishes the principles and requirements for the competence and impartiality of product, service and process certification and for the bodies offering these services. ISO/IEC 17065:2012: TÜV SÜD certified Read the full article Medical Device Regulation (MDR) The new Medical Device Regulation, which will replace today's Medical Device Directive (MDD), is currently on its long way through the European Parliament. The new Medical Device Regulation (MDR) Read the full article New developements in ultrasound
Whenever ultrasound is used not only general aspects such as electrical and mechanical safety, but also essential biological effects have to be addressed that ultrasound waves have on human tissue.
Read the full article Russia: New rules governing registration Russia: New rules governing marketing authorisation
All Medical Devices circulated in the Russian Federation have to be registered. With effect from January 1, 2013, the rules governing registration have changed.
Read the full article New Service: Software certification TÜV SÜD is now offering its clients a new service – the certification of Medical Device software in accordance with the criteria of the IEC 62304 standard. Software certification in accordance with IEC 62304 Read the full article EU: New list of standards for medical devices The new list of harmonized standards on the EU website provides an overview of the most recent changes that have come into effect in January 2013. New list of harmonised standards for Medical Devices Read the full article Mirandola: One year after the quake Since the earthquake of May 29, 2012 which landed a second annihilating blow on the entire region and paralyzed around 70% of production capacities, they are busy rebuilding their industry. The miracle of Mirandola: Rolling up their sleeves after the quake Read the full article