E-Learning – E-Learning und Webinare
Webinar: General Safety and Performance Requirements (GSPR)

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:

Which requirements of the MDR must be fulfilled?
In what way can these be implemented with reasonable effort?
Which standard documents and records are needed?
Which competences are needed in the documentation team and how can they be coordinatated efficiently?
What does internal quality assurance look like before submission?

Ihr Nutzen

Practical knowledge of the MDR from the perspective of the Notified Body.
Sustainable, interactive approach to transfer knowledge.
Assistance with ambiguities and best practice.
You will receive a certificate for attending the webinar.
The webinar consists of coordinated modules and topics.

Teilnehmer

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.

Inhalte

Relevant regulatory requirement from theMDR
Requirements for documentation of General Safety and Performance Requirements
Implementation in practice

Besondere Hinweise

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.

Technical requirements:

Google Chrome v31 (or higher) web browser
A terminal device (PC or Laptop) with audio output
Windows 10; Mac OS X 10.9 or higher
A stable internet connection (recommended: at least 1 MB/s)
GoToTraining Desktop-App (JavaScript enabled) – you will receive the link to download the app a few days prior to begin of the training
A working microphone (external microphone or headset recommended)
A Webcam

Ihr Plus

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.