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This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
Russ Gray
Instructor Russ Gray
Product Id 601286
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

FDA’s Enforcements for Mobile Medical Applications

Overview:

Information provided will allow an attendee to determine if their App is a medical device, and if it is, determine the regulatory obligations the App will carry. Guidance will also be provided as to adjusting the intended use claims for an App that might take it out of the definition of a medical device. Recommendations will be provided for getting started with medical device regulations if your App is a medical device.

Why should you attend: Software developers may be creating software Apps that meet the definition of a medical device according to the Food, Drug and Cosmetics Act. Medical device software Apps are subject to medical device regulations and the software must be developed to meet the FDA’s Quality System Regulation requirements. Failure to do so may result in your App being recalled from the market.

Areas Covered in the Session:

  • Legal definition of a medical device
  • How product claims and capabilities bring an App under the medical device definition
  • Adjusting product claims and features to take a product out of medical device regulatory obligations
  • FDA’s Mobile Medical Apps guidance
  • FDA enforcement discretion of Mobile Medical Apps
  • Regulatory obligations for software Apps that are medical devices
  • Getting started with medical device regulations if your App is a medical device

Who Will Benefit:
  • Software developers creating mobile software applications for healthcare or health maintenance
  • Hospital IT managers overseeing development of healthcare software applications
  • Cloud IT managers hosting Apps that might be medical devices

Speaker Profile
Mr. Gray has over 40 years of experience in the life science industries. He has broad experience in product development and technical management in medical devices, in-vitro diagnostic instrumentation, analytical instrumentation, and combination pharmaceutical-device products. His expertise includes product design control and risk management systems, compliance with FDA and ISO requirements, integration of these requirements with phase gate product commercialization processes, as well as regulatory submission consulting for software-intensive products.

His early career was focused on engineering, product development, and engineering management. He was a member of project teams that developed groundbreaking computer-controlled in-vitro diagnostic, analytical instrumentation, and machine-tool products. More recently, Mr. Gray has spent substantial time helping drug manufacturers enter the world of devices and combination products. Engagements in this realm include helping drug companies design part 820-compliant quality systems, developing design control and risk management systems for outsourced device development scenarios, developing global regulatory submission strategies for drug delivery devices, and developing contract manufacturing strategies for high-volume combination devices.

Mr. Gray is especially expert on leading his clients through quality system architecture, human factors engineering and high-volume medical device manufacturing challenges. His clients range from Fortune 100 corporations to start-up companies.
Background : 
Many companies are building software applications (Apps) for mobile platforms (smart phones, tablets). Companies developing healthcare and health maintenance applications should be aware of medical device regulations possibly affecting their Apps.

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