IEC 62304 for Medical Device Software 2019

Topics

• 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

Who should Attend

• Regulatory Affairs Departments
• Quality Assurance Departments
• Compliance Departments
• Quality Engineering Departments
• Medical Device Software Manufacturing Departments
• Software Engineering Departments