E-Learning – E-Learning und Webinare
Webinar: Post Market Surveillance

Irrespective of the legal framework: From 26.05.2021 onwards, medical device manufacturers must establish an effective system of market surveillance and comply with the relevant requirements of MDR 2017/745, even if the company is not yet certified according to the regulation. Notified Bodies are required by surveillance authorities to explicitly verify compliance through surveillance and unannounced audits, also under MDD 93/42/EEC.

Many manufacturers of medical devices are currently asking themselves the following questions, among others:

• How do I deal with the specific MDR requirements for the PMS?
• What role does the PMS play during the product life cycle?
• How is a PMS system established?
• How do I create MDR-compliant specification documents for the PMS?
• How do I continuously collect data for PMS activities?
• How do I submit data to the competent authority?

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, who are entrusted with the task of installing and maintaining an MDR-compliant post-market surveillance system

Inhalte

• Relevant regulatory requirement from the MDR
• Requirements for Post Market Surveillance 
• Implementation in practice

Besondere Hinweise

This webinar series takes place in virtual sessions of 4 hours each. Splitting up in groups, solutions are found in a high level of interaction, conveying the learning 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.

Cooperation

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

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