Mobile Medical Applications: Software Regulatory Requirements

Instructor: Tim Stein
Product ID: 702812
Training Level: Intermediate
  • Duration: 90 Min
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2014

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Fax: +1-650-362-2367


Read Frequently Asked Questions

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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