Requirements to place Medical Device Software and Health Software on the market

Course description

This training covers the regulations and standards applicable to Medical Device Software: mobile medical apps, web apps, connected objects, cloud software and/or standalone software for diagnosis or planning. It tackles questions about the parameters to qualify as medical device or outside medical device (other function in FDA language), and their interactions.

It also covers Health Software, not regulated as medical devices like software managing patient information.

Course outline

• Session 1 – How to classify and quality software:
  • Introduction
  • Worldwide overview of Regulations
  • The CE Mark and the CE Directives
  • The 21 CFR and FDA guidances
  • Qualification, classification of software as medical device
  • ISO and IEC standards for software medical devices
  • Paths to Clearance and CE mark
• Session 2 – IEC 82304-1
  • Why IEC 82304-1, Scope
  • Relationships with other standards: ISO 13485, ISO 14971, IEC 62304, and IEC 81001-5-1
  • Software Requirements
  • Software Validation
  • Requirements on Instructions for Use
  • Requirements on Post-market
• Session 3 – IEC 62304
  • Introduction, terms & definitions
  • General Requirements, software safety class
  • Software Development Process
• Session 4 – IEC 62304 (continued)
  • Software Development Process (continued)
  • Software Risk Management
  • Software Maintenance

Learning objectives

During this training, you will learn:

• how to qualify and classify standalone software
• what regulations are applicable to your software: CE marking, FDA
• how to apply standards related to software : IEC 82304-1, and IEC 62304
• how to coordinate ISO 13485 and ISO 14971 with IEC 82304-1, and IEC 62304

Who should attend

Medical Device professionals who are involved in the following areas:

• Development of medical devices containing software, and software as stand alone medical devices
• Risk assessment of software based product
• QA/RA managers within companies with Medical Device Software or Health Software development
• Purchasers involved in the purchase of Software development from subcontractors
• Project managers handling sub-contracted Software development

Prerequisites

• You should have basic knowledge of how to perform scientific data base searches
• You should have experience in writing regulatory reports /medical writing
• You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).

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