Certification of medical device software

The webinar will provide essential information regarding the prerequisites that a software must meet in order to qualify as a medical device. Specifically, for Medical Devices containing software or stand-alone software, prefessionals responsible for quality management and regulatory affairs, software and systems deisgners, interface/usability and requirements designers will benefit from a training and acceleration session aimed at aligning and/or advancing the design activities of a medical device software. 

Goal of the webinar 

The meeting will provide an overview of the activities that a company must implement in order to certify medical device software. Specifically, after defining what is meant by medical device software, the classification rules in MDR and IVDR applicable to stand-alone software as medical devices and software embedded in medical devices will be presented. Finally, key information will be shared regarding the compilation of the Technical File for stand-alone medical device software or software embedded in a medical device. 

Program

• Introduction: general overview of the international legislative and regulatory framework applicable to Medical Devices, with a specific focus on stand-alone software and software embedded in medical devices. 
• When a software is considered a medical device (MDSW) 
• Classification of software as medical devices in accordance with MDR/IVDR Annex VIII
• MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR. 
• Technical Documentation for stand-alone or software-embedded devices
• How to document 

Useful information 

Duration: 11:30 am - 12:30 pm 

Delivery mode: online 

Course language: italian