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

ONLINE 2-3 and 5-6 November 2020

Course description

This online 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).

#5252

Share
Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp
Share on email
Date & Time
November 2, 2020
- November 6, 2020
4 days 8.30-12.30
IndustryMedical Device
LanguageEnglish
LevelIntermediate
LocationOnline
RegionGlobal

2 050,00 1 850,00

No. persons

make an inquiry

In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

We take great care of your contact details. To learn more, read our Privacy Policy

Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Cyrille Michaud

Search

Cookies

For your best experience are we using cookies on this website.