Bioforum ISO 13485:2016 & new EU MDR event 0
Posted on 15, December 2016
in Category News
On December 13 and 14, Bioforum Ltd in Israel organized 2 days on new QMS and regulatory developments in the medical device industry. On the first day, despite the unusual stormy weather, a full room paid close attention to the changes between the QMS standards ISO 13485:2003 and ISO 13485:2016. Both Robert van Boxtel and Veronique Jasner presented the details on what is new and changed in this international standard. At the end of the day, the most effective approach to perform a gap analysis was presented. And, the message is clear: make sure that your QMS is upgraded and audited in 2017. Because in 2018 and on, there will be the next challenge facing the medical device industry.
This was the subject on the second day of the seminar: the proposed text of the European Medical Device Regulation was discussed, as Robert van Boxtel presented a number of specific requirements such as conformity assessment routes, technical dossier requirements, QMS requirements, M.A.I.D. responsibilities, PMS, Clinical evaluation, etc. The message is clear, you can already start the preparations by implementing requirements on clinical investigation, clinical evaluation and PMS/PMCF. Another item turning out to require attention are the new responsibilities of the distributors and importers, how to make those aware of their responsibilities. Finally, find out how your Notified Body is preparing: will they still be around once the new EU MDR is published?
Through the excellent support of Bioforum and the active participation of the attendees, we can look back on a successful event. Looking forward to the next seminar on this subject.