The ABCs of Medical Device Software Compliance under EU Regulations 2017/745 and 2017/746 - Webinar

Celegence (https://www.celegence.com/) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams. During our Medical Device Virtual Summit – 2021, April Komplin presented a feature presentation titled “The ABCs of Medical Device Software Compliance under EU Regulations 2017/745 and 2017/746.” Why should you watch this presentation? 1. To review the medical device software (MDSW) classifications and include a discussion of their implications under the MDR and IVDR 2. To understand the key requirements for MDSW technical documentation under the MDR and IVDR, including the risk assessment, performance evaluation, and post-market surveillance plans Celegence’s expert medical device team can provide you with flexible and specific services based on your particular therapeutic area, classification of the device, and notified body requirements to be compliant with all the EU MDR requirements. For more information, reach out to us at [email protected].