This message is sent to you by FDA Newswatch

Medical Device Software 62304 Compliance

Thursday, 12 July 2018 10:00 AM PDT, 01:00 PM EDT

Training Duration = 60 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

The reliability of medical device software and the risk associated with it has become a key concern. One of the biggest risks you can face when submitting your software-enabled medical device for approval is finding out - after months of waiting - that the 510K has been denied because the software is noncompliant.

You also face potential audit risk that might prevent you from selling your product if doesn't have IEC62304 compliant software quality system.

Let's face it: developing software for medical devices can be a challenge - especially if the device is complicated. You don't know whether it's safe enough, or tested enough - or whether the FDA will consider it suitable for a 510K. And if your software fails and harms someone, you don't know whether you're protected from liability. So what are your options?

Learning Objectives:

  • The regulatory need for IEC62304 guidance
  • What constitutes compliance to the standard?
  • How IEC62304 fits in with a company's standard quality process
  • What areas does the guidance address?
  • What are the legal consequences if your company does not adhere to the guidance?
  • One of the most common reasons for 510K denial
  • What are the potential audit consequences if your company does not have an IEC62304 compliance quality system in place?

Why Should You Attend:

Compliance to IEC62304 is the key to ensure that your software has been developed to the highest level of safety - and that your medical device is safe. It gives you a framework to ensure that you are developing and testing to consistent and stringent standard. Demonstrating compliance will be apparent in your submission - and one way to ensure acceptance by the FDA.

In this webinar speaker will show you how to confidently prepare for and get 510 K approval from the FDA for your software enabled medical devices. She will show you exactly what documentation to prepare and how to prepare it correctly - so that the software portion of the submittal is in compliance with IEC62304.

She will explain how IEC62304 differs from other compliance standards such as ISO13485, its benefits, the elements that constitute an IEC62304 compliant system - as well as the components of the software lifecycle, along with examples of major software products developed to the standard.

You will know how to fit IEC62304 with your company's standard quality process, the legal consequences of not adhering to the guidance, the most common reason for denial of 510K approval and the potential audit consequences if your company does not have an IEC62304 compliance quality system in place.

Areas Covered

  • Why is having an IEC62304 compliant software quality system important to both developing your software for 510K approval and how you can be putting your company at risk post approval if you do not have a compliant system in place?
  • What is IEC62304 and how does it differ from other compliance standards such as ISO13485?
  • What are the elements that constitute an IEC62304 compliant system?
  • What are the benefits of developing to IEC62304 standard?
  • What are the components of the software lifecycle?
  • What are the major software products developed to the standard?


Nancy Knettell, Founder and Principal at Signet Medical Systems, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer.

Along with her senior level management experience with cross-functional program teams for major companies such as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic.

But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.