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Medical device software (IEC 62304)

Opleiding

The IEC62304 standard provides a framework of life cycle processes necessary for the safe design and maintenance of medical device software. Today, the majority of medical device manufacturers develop their software in a process compliant with IEC62304.

IEC 62304 proposed a risk-based classification and specifies process requirements for each class.

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software does not lead to any unacceptable risks.

Praktisch

04/10/2017 9u - 17u Hasselt
Schrijf in

Prijs

LEDEN € 630
NIET-LEDEN € 725

KMO-portefeuille: vraag hier uw subsidie aan en bespaar tot 40% op uw inschrijvingsprijs.
Erkenningsnummer Allanta: DV.O105117

 

Word lid

Uw opleiding in detail

Agendapunten

  • Background of IEC62304
  • Classification and relation to risk management
  • Software Development
  • Software Maintenance
  • Configuration and change management
  • Software risk management
  • How to show compliance with the standard
  • Practical documentation examples
  • Using IEC62304 with Agile software development

UW LEER-
RESULTATEN

  • Understand all clauses of IEC62304
  • Be able to use IEC62304 during medical device software development
  • Understand how to prepare minimal but sufficient documentation

Uw
certificaat

All students who attend 75% of classes, will receive a certificate of participation.


Uw
docent

Paul Theunissen ondersteunt en begeleidt healthcare providers en Medical Device bedrijven met Regulatory Compliance.

Na het behalen van zijn Masterdiploma Electrical Engineering werkte Paul gedurende 15 jaar in verschillende (Medical) Device ontwikkeling en productie ondernemingen. Initieel als project manager. In deze hoedanigheid voerde hij vele multidisciplinaire ontwikkelingsprojecten uit. In 2004 zette Paul de stap naar quality & regulatory consultancy. Sindsdien faciliteerde Paul vele externe audits en FDA inspecties en lanceerde hij verscheidene producten op de markt. Sinds 2010 is Paul actief als senior consultant voor Allanta vzw.


Uw Contact-
persoon

Cyriel Frère

TEL +32 (0) 11 870 944

info@allanta.be





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