No other industry is as complex and yet as sensitive as the medical industry. People rely on the testing of every medical device by impartial and expert specialists before it is approved for use. It is not without reason that these tests are carried out by impartial third parties such as TÜV SÜD.
As an impartial and pragmatic testing and certification organisation, we have contributed to the high standard of the "Made in Germany" label.
Our TÜV SÜD certificates are important for many German and international medical device manufacturers to supply premium-quality medical devices and succeed on the market. As the largest Notified Body, our priority is to be your expert and trustworthy service provider throughout the entire product life cycle – at local and global level.
I hope you find our newsletter an interesting and informative read.
Best regards, Dr. Peter Havel Senior Vice President, Medical & Health Services Global
Unannounced audits: What to expect from product testing of high risk devices Tyvek® transition: Questionnaire to simplify requalification Approval of wearables EU Directive 93/42/EEC: How to address risks in instructions for use Proactive update of Clinical Evaluation Reports (CERs) Experiences with testing according to IEC 60601-1 3rd ed.
Between PIP and MDD - Thorough audits for more patient safety Medical Device Single Audit Program (MDSAP) - Multilateral audit initiative launched as a pilot program RoHS II for Medical Devices - Dynamic changes in Environmental Protection Directive ISO 14971 - Guidance on the standard now published INMETRO accreditation - Access to the Brazilian market MDA/CAB-001 - TÜV SÜD Malaysia approved and registered as a CAB
Unannounced audits - EU Commission establishes basis for unannounced audits Malaysia - First Medical Device Act in effect Medical Device regulation in Japan IEC 60601-1:2005+A1:2012: Strategies for a successful changeover to the 3rd edition Reprocessing of neurosurgery Medical Devices Post-market data: Checklist for complete documentation
ISO/IEC 17065: TÜV SÜD certifiedThe new Medical Device Regulation (MDR) New developments in ultrasound Russia: New rules governing marketing authorisation Software certification in accordance with IEC 62304 New list of harmonised standards for Medical Devices The miracle of Mirandola: Rolling up their sleeves after the quake