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Medical Device Software and Health Software

Key2Compliance®
2 dage
Kursus
København
15.750 DKK ekskl. moms

Hvorfor vælge Key2Compliance® ?

Markedsleder - Kvalitetsbevidst og med certificeret kompetence

Flere leveringsløsninger og nem adgang til viden - Fleksibilitet

God atmosfære med kooperative og tilgængelig undervisere

Kursusbeskrivelse

medical

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

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 outcome

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

Course description

The course will touch upon the following topics:

  • 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
  • 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
  • IEC 62304
    • Introduction.
    • History of software standards in medical devices.
    • Terms & definitions
    • General Requirements
    • Software Development Process
    • Software Risk Management
    • Software Maintenance

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.

Målgruppe

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

Pris

Price of this course is 15.750 dkk excl. VAT.

Early bird price: 13.750 dkk excl. VAT.

Om udbyderen

Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse.  Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...


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Kontaktinfo

Key2Compliance®

Tietgensgade 65
1704

Telefon: +46 (0)8 544 811 60

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