Skip to content
Regulatory knowledge for medical devices
Articles on the development and approval of medical devices and other regulatory topics
Regulatory knowledge for medical devices
CONTACT USLogin
Search:
  • Consulting
    • Market Access
      • Market Access US & International
      • Market Access Europe
      • MDR / IVDR Consulting
      • IVD Admission Strategy
      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
    • Technical Documentation
      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
    • Seminars
      • Seminar Overview
  • Digital Transformation
  • Medical Device University
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • About us
    • The Company
      • Our Mission
      • Our Values
      • Certificates
    • People
      • The Team
      • Our Customers
    • Locations
    • Jobs at Johner Institute
      • Current Vacancies
      • Why the Johner Institute?
  • Consulting
    • Market Access
      • Market Access US & International
      • Market Access Europe
      • MDR / IVDR Consulting
      • IVD Admission Strategy
      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
    • Technical Documentation
      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
    • Seminars
      • Seminar Overview
  • Digital Transformation
  • Medical Device University
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • About us
    • The Company
      • Our Mission
      • Our Values
      • Certificates
    • People
      • The Team
      • Our Customers
    • Locations
    • Jobs at Johner Institute
      • Current Vacancies
      • Why the Johner Institute?
You are here:
  1. Home
  2. 2015
  3. September
  4. 15

September 15, 2015


Software unit: specifying and testing according to IEC 62304

By Janos HackenbeckSeptember 15, 2015Leave a comment

The term software unit is defined in IEC 62304. Many manufacturers experience difficulties when specifying and testing these software units. This article gives you tips on how to avoid them.

Details

Stay informed with our newsletter!

Medical Device Briefings

Your trustworthy source to safely navigate the medical device regulations.

SIGN UP
  • LinkedIn
  • Locations
  • GTC
  • Login
  • LinkedIn
JI Bottom Bar
Go to Top