Mobile Medical Applications: Software Regulatory Requirements

Why Should You Attend:

Developers of medical device cell phone / smart devices apps often find out about the relevant regulatory requirements late in the development process. Then it is very difficult to pull together what is needed to 510(k) FDA market clearance, or to create the technical file needed to get a CE Mark. In addition, most likely the app was not developed under quality system requirements.

This presentation will begin with a brief examination of the definitions and types of mobile platforms and mobile medical applications. Participants will then gain information on current FDA and European requirements for the manufacturers of mobile medical applications and guidance on a regulatory approach to these emerging applications. The instructor will discuss requirements for the software development processes and the artifacts that should be generated during development.

This session will answer all of the following:

• When is a mobile app a medical device?
• What medical device regulations / standards apply to the development of mobile medical apps?
• What should I do, while developing the software, to create what is needed for an FDA submission or an EU technical file? What software development artifacts do I need to have?
• My app is developed and I have no artifacts. How do I get a 510(k)?

Areas Covered in the Webinar:

• When is a mobile app a medical device
• When is a mobile device platform a mobile medical device platform
• FDA Guidance: “Mobile Medical Applications”
• Review of quality system requirements from the FDA (QSRs) and the EU (ISO 13485)
• Review of software development standards: ISO 62304 and FDA guidance documents
• Review of HIPAA IT security guidance as applicable to mobile medical app
• Review of what a medical device app submission to the FDA needs to include
• Review of what a technical file needs to include for a medical device CE Mark
• Medical Device Data Systems (MDDS)
• FDA Enforcements and ISO Audit Observations

Learning Objective:

To obtain a basic familiarity with the regulatory requirements for medical device app development, both the engineering process and artifacts

Who will Benefit:

This webinar will benefit professionals from the medical device sector who are responsible for

• Medical device software design and development
• Medical device software Verification and Validation
• Medical device project management
• Software Quality Assurance
• Regulatory Affairs
• Product Managers
• Marketing

Instructor Profile:

Tim Stein, Ph.D. founded Business Performance Associates, Inc., a consulting firm located in Cupertino, California, in 1994. Tim’s has provided services to over 95 clients in software regulatory compliance and development, establishing and improving quality systems, and the preparation of regulatory submissions. Tim served as the Director of Software Validation and Quality Assurance at Genomic Health, Inc. During the past few years, Tim has focused on IEC 62304 gap analyses and providing leadership in establishing compliant software development processes for both well established companies and startups. He is the author of The Computer System Risk Management and Validation Life Cycle. Tim, a frequent speaker at webinars and national events, is a Fellow of the American Society for Quality.

Bill Kurani, MSRA MSEE), BC has extensive experience in the area of regulatory affairs and quality assurance of medical device and drugs. Mr. Kurani has helped several medical device companies implement successful product design, development, verification, validation, and manufacturing process programs. He has done hazard and risk analysis on many aspects of the medical device product and manufacturing process before clearances and approvals. Mr. Kurani has secured regulatory marketing clearances and approvals from FDA, the EU, and other global regulatory bodies.

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