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?
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.
Join this webinar, where medical device expert Nancy Knettell will show you how to get 510K 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 to 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.
After attending the webinar, you will you know how to confidently prepare for – and get – a 510K approval from the FDA for your software enabled medical devices.
After attending webinar, you will clearly understand:
This session will answer critical questions, such as:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Casper E. Uldriks
Nancy Knettell is founder and principle of Signet Medical Systems, LLC. She has more than 30 years in combined Regulatory, Software Development, and Software Quality experience, primarily in the medical device industry. Knettell has also consulted with major medical companies, including Johnson & Johnson, Smith and Nephew, Philips Medical, CR Bard, and Hologic. For Knettell, involvement in the medical device industry is a personal issue. Having lost her...
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