Why Should You 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 Webinar:
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
What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance
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
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 Webinar:
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
What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance
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
Speakers
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
