February 28, 2023

Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes

medical device software

In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging from cyber security, medical image devices, and mobile medical applications. Furthermore, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations related to how software is regulated, classified, and qualified.

You may be asking yourselves:
– Is my software considered a medical device?
– How do I address the clinical evaluation for my medical device software?
– How do I define the safety and performance outcomes, and other clinical evaluation parameters?

Join us for answers to these questions and to find out more about the topic of software as a medical device!

Watch the recording of this webinar here.

Who should register for this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve clinical evaluation reports for MDR submissions.
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November 16, 2022

[FEATURED] Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled at Highest Levels

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

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November 3, 2022

[FEATURED] EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

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October 22, 2022

[FEATURED] More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews 

Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.

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September 25, 2022

[FEATURED] EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble for Manufacturers

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.

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