This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company’s face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. They also face potential audit risk which might prevent them from selling their approved product if they have been found to not have an IEC62304 Compliant Software Quality System.
This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly so the software portion of the submittal will be in compliance preventing delays of the 510K 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 510K to prevent this risk.
Why You Should Attend:
Developing software for medical devices can be a challenge especially if the device is complicated. You do not know if it is safe enough. You do not know if it tested enough. You do not know if the FDA will consider it for suitability for a 510K. Should your software cause harm to someone you don’t know if you are protected from liability should your software fail.
Compliance with IEC62304 is key to ensure your software has been developed to the highest level of safety. Developing software based on the standard shows one way to indicate an intent to ensure the safety of your product. Gives you a framework to ensure you are developing and testing to consistent and stringent standard. Demonstrating compliance with the standard will be apparent in your submission and will be one way to ensure acceptance by the FDA.
Areas Covered in the Session :
- 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?
- Benefits of developing to an IEC62304 standard
- What are the components of the Software Lifecycle
- What are the major Software Work Products developed to the standard?
- How it fits in with a Company’s Standard Quality Process
- One of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed
- What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place
- Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
- What constitutes compliance with the Standard
- What areas does the Guidance Address
- What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance
Who Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Quality Engineering Departments
- Compliance Departments
- Software Engineering Departments
- Medical Device Software Manufacturing Departments
Course Director: NANCY KNETTELL
Nancy Knettell, Founder and Principal at Software510K, 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.