Medical device software regulations in the EU

Denna kurs erbjuds av vår nätverkspartner Qadvis.

There are significant changes in the EU regulations regarding medical device software. This training represents our current knowhow with a future perspective.

To update you on the status of the regulatory requirements on medical device software according to MDR 2017/745 and IVDR 2017/746. To convey the best ways how to utilize the core medical device software-related standards IEC 62304 and IEC 82304-1 in practice for compliance in the EU. To improve the understanding of medical device software risk management (including an update on the latest cybersecurity standards) and clinical evaluation of medical device software. The training covers software as part of a medical device and software that are devices in themselves (SW as a medical device).

This training is intended for anyone working with software which is, or may become, classified as a medical device. This includes for example software engineers and quality & regulatory professionals working at medical device companies, research units or healthcare units developing medical software and digital health products or services.

This webinar will be held in English.

Praktisk information
Datum: 3 juni 2021
Tid: kl. 09:00 – 16:30

Läs mer om kursen här >>

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