Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on August 26 for a discussion of the webinar

In vitro diagnostic (IVD) medical device Software, whether standalone or on a device, will now face a higher level of Regulatory Compliance based on the new IVD Regulations (IVDR) coming in May 2022. Any IVD Companies interested in commercializing their IVD Software will also now require FDA 510K Clearance to be able to sell their products. Learn what is required to successfully support the IVDR standard/510k regulatory requirements by ensuring IEC62304 Compliance with software.

Webinar Takeaway

This course will ensure that IVD Diagnostic companies that depend on custom software to deliver their service will know exactly what documentation needs to be prepared to ensure compliance and prevent costly revenue interruptions due to failed unannounced audits as required by the new IVDR 2022 regulations. They will also know how to ensure the documentation is prepared correctly specifically for the software portion of the submittal so that it will comply preventing delays of the 510(k) approval.

 Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510(k) to prevent this risk.

Key Learning Objectives

  • 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.

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

Who will Benefit

  • IVD Medical Device Software Regulatory professionals,
  • IVD Medical Device Software Quality Assurance Engineers,
  • IVD Medical Device Software Quality Senior Management,
  • IVD Medical Device Software Company Senior Management
  • IVD Medical Device Quality Engineers
  • IVD Medical Device Quality Senior Management 

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Faculty Nancy Knettell

Faculty Nancy Knettell

Nancy Knettell, Founder and Principal at Software510, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry for such major medical device companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Deka Research, Becton Dickenson, and Johnson and Johnson.

Choose a Purchase Options

$287

Live Webinar - Single Participant 60-mins

Special Offer Attend live and get Free Recorded Access for 6 month

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.