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, and/or standalone software for diagnosis or planning.

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
  • Application to software medical devices
  • 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
  • Software Requirements
  • Software Validation
  • Requirements on Instructions for Use
  • Requirements on Post-market
• Session 3 – IEC 62304
  • Introduction
  • History of software standards in medical devices
  • Terms & definitions
  • General Requirements
  • 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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