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EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
- Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
- What constitutes compliance to the Standard
- How it fits in with a Company's Standard Quality Process
- 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.
- Once of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidiance has not been followed
- What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place.
- Additional Information for CyberSecurity and Usability as it relates to Software Design
- Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
- What constitutes compliance to the Standard
- How it fits in with a Company's Standard Quality Process
- 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.
- Once of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidiance has not been followed.
- What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place
Overview of the webinar
This course is essential for Medical Device and IVD 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.
Who should attend?
- Vice President of Regulatory
- Director of Regulatory
- Vice President of Quality
- Vice President of Compliance and Regulatory
- Regulatory Expert
- Compliance Expert
- Software Engineer
- Software Engineering Manager
- Software Compliance Engineer
- Medical Device Software Engineer
- Quality Engineer
- Quality Assurance
- Quality Manager
Why should you attend?
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.
Faculty - Ms.Nancy Knettell
Founder and Principle, SoftwareCyber510K, LLC
Nancy Knettell, Founder and Principle of SoftwareCyber510K, LLC has over 30 years in Regulatory, Software Development, and Systems Engineering experience primarily in the Medical Device industry consulting to major Medical Device and IVD companies such as Cook Medical, Johnson and Johnson, ThermoFisher Scientific, Smith and Nephew, and Genomic Health.
Involvement for Nancy, in medical device development, is a personal issue as well. Having lost her father at an early age to heart disease, she now wants to work to help others facing such life threatening events by advancing the potential for life-saving medical devices through the use of quality based software engineering systems.