IEC 62304 for Medical Device Software 2019 is a webinar that covers topics such as:
- What is IEC62304 and how does it differ from other Compliance Standards such as ISO13485
- 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
- Benefits of developing to an IEC62304 standard
- What are the elements that constitute an IEC62304 Compliant System?
- What are the major Software Work Products developed to the standard?
- What are the components of the Software Lifecycle
- One of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed
- How it fits in with a Company’s Standard Quality Process
- The regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices
- What are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place
- What areas does the Guidance Address
- What constitutes compliance with the Standard
- What are the legal consequences for the company with the submittal if the company does not adhere to the Guidance
IEC 62304 for Medical Device Software 2019 is intended for:
- Regulatory Affairs Departments
- Quality Assurance Departments
- Compliance Departments
- Quality Engineering Departments
- Medical Device Software Manufacturing Departments
- Software Engineering Departments
