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. 2016
  3. March
  4. 07

March 7, 2016


Software audit: What really matters

By Claudia SchmittMarch 7, 2016Leave a comment

“Will a software audit take place?” is a question that reached me via our micro-consulting. ‘And can I avoid a software audit by choosing the appropriate software safety class?” At first, I didn’t realize exactly what ‘software audit’ meant or what the exact concern was. But then I understood and found the question to be…

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