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Medical Devices Regulation MDR Postponed.

Medical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…

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COVID-19

While the world is fighting against the virus, company fighting about economical crisis, certificates are still expiring and notified bodies and auditing organizations have to look for new ways to work. Our partner GMED NA, has put in place exceptional provisions for certification audits impacted by this health crisis. Depending on the type of audit,…

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ISO 13485:2015 to be published early 2016

Reference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…