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A medical device manufacturer, who can manage and apply the General Safety and Performance Requirements, does not need to fear the submission of the technical file. Doing it right the first time will not only save unnecessary and time-consuming correction loops that delay the conformity assessment procedure as a whole, but also a lot of money. In no other industry have the daily rates of assessors developed so dynamically as in product assessment. Due to the substantially increased qualification requirements of the MDR for experts, an extra loop can quickly cost a five-digit sum and, moreover, further thin out the rare capacities. This webinar was developed for "Do it right the first time".
Many manufacturers of medical devices are currently mainly asking themselves:
This webinar is adressed to responsible persons and employees of medical device manufacturers from QA/RA, F&E, Service and Support as well as production, who are entrusted with the task of documenting and maintaining the General Safety and Performance Requirements of the MDR in a targeted manner.
This webinar series takes place in virtual sessions of 4 hours each. Spliiting up in groups, solutions are found in a high level of interaction, conveying the acquired content in a sustainable manner.
The cooperation of DGQ / DQS MED – both established providers in further education and conformity assessment – combines complementary competences in didactics and contents and imparts sustainable knowledge applicable in daily practice. Competent experts from a Notified Body for medical devices act as speakers.
Up to 2 trainers are also available to answer questions at any time.
The results of the group work with recommendations for action from the perspective of a Notified Body are made available digitally afterwards.
The webinar series around the EU Regulation MDR 2017/745 consists of 15 main topics in total.
All further dates can be found here: https://shop.dgq.de/themen/e-learning
Zur Zeit gibt es keine öffentlichen Termine zu dieser Veranstaltung.