Software As A Medical Device (samd) New Ivdr Document Requirements

By Author: Compliance4all
Total Articles: 13
Comment this article

Software As a Medical Device (SaMD): New IVDR Document Requirements
IVD medical device companies should ensure that their software enabled medical devices or software as an IVD medical device is compliant to the new software requirements in the IVDR 2022 regulations. This is the only way by which they can avoid stringent actions that follow from non-implementation, which will affect their revenue, as well as their reputation.
Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will, at a webinar it is organizing on February 20, explain all that is required for IVD medical device companies to ensure proper compliance with the upcoming new IVDR 2022 regulations.
Nancy Knettel, Founder and Principal at SoftwareCyber510, LLC, will be the speaker at this sixty-minute session. Please log on to Compliance4all to enroll for this valuable session.
-----------------------------------------------------------------------------------------------------------------
At this webinar, Nancy will explain just what documentation is needed for an SaMD company ...
... to file for a 510 (K) regulatory filing. In particular, she will stress what needs to go into the software part of the submittal, which can help ensure compliance with the requirements, which can prevent delays in the 510 (K) approval.
The learning gained at this webinar will help the participants:
• Know how to ensure the software documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance with the latest 2022 IVDR regulations
• Avoid potential audit risks and serious findings which can prevent a company’s ability to sell their service
• Know what is expected to have in place for compliance for your company if you wish to prepare a 510(k) filing if you plan to sell your software
• Ensure a faster 510(k) approval because the documentation is complete and comprehensive
• Prevent costly time to market issues because 510(k) has been rejected completely because of software
Professionals in the areas of IVD Medical Device Software, such as regulatory professionals, Quality Assurance Engineers, Senior Management, Quality Engineers, and Quality Senior Management will gain important learning from this course.
----------------------------------------------------------------------------------------------------------------
About the expert: Nancy brings more than three decades of experience in the regulatory and software development areas, primarily in the IVD and medical device industry. During this period, she has worked for companies such as Genomic Health, BioRAD, Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, and Johnson and Johnson.