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:
  • Academy
    • Seminars, Courses, and Workshops
  • Consulting
    • Market Access & Regulatory Affairs
      • In-house Production of IVD Medical Devices
      • US Market Access
      • International Approval
      • Clinical Strategy
      • IVD Performance Evaluation Strategy
      • MDR/IVDR Approval
    • Management Systems
      • Quality Management Systems (QMS)
      • QMSR Consulting
      • Information Security Management System (ISMS)
      • Integrated Management Systems (IMS)
    • Technical Documentation
      • Biological Safety
      • Electrical Safety & EMC
      • Clinical Evaluation
      • Shelf Life and Transport­ation Validation
      • IT Security
      • Clinical Evaluation
      • IVD Performance Evaluation
  • Product Testing
    • IVD Performance Studies
    • Clinical Trials and Studies
    • Biocompatibility Testing
    • Usability Evaluation
  • Outsourcing
    • Authorized Representative Services & Regulatory Roles
    • Legal Manufacturer EU
    • US Agent
  • Regtech & AI
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • The Institute
    • Our Mission & Values
    • Our Company History
    • Who We Are
    • Locations
    • People
    • Customers & Partners
    • Locations
    • Jobs at Johner Institute
  • Academy
    • Seminars, Courses, and Workshops
  • Consulting
    • Market Access & Regulatory Affairs
      • In-house Production of IVD Medical Devices
      • US Market Access
      • International Approval
      • Clinical Strategy
      • IVD Performance Evaluation Strategy
      • MDR/IVDR Approval
    • Management Systems
      • Quality Management Systems (QMS)
      • QMSR Consulting
      • Information Security Management System (ISMS)
      • Integrated Management Systems (IMS)
    • Technical Documentation
      • Biological Safety
      • Electrical Safety & EMC
      • Clinical Evaluation
      • Shelf Life and Transport­ation Validation
      • IT Security
      • Clinical Evaluation
      • IVD Performance Evaluation
  • Product Testing
    • IVD Performance Studies
    • Clinical Trials and Studies
    • Biocompatibility Testing
    • Usability Evaluation
  • Outsourcing
    • Authorized Representative Services & Regulatory Roles
    • Legal Manufacturer EU
    • US Agent
  • Regtech & AI
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • The Institute
    • Our Mission & Values
    • Our Company History
    • Who We Are
    • Locations
    • People
    • Customers & Partners
    • Locations
    • Jobs at Johner Institute
You are here:
  1. Home
  2. 2023
  3. March
  4. 27

March 27, 2023


IEC 81001-5-1: The standard for secure health software

By Christian RosenzweigMarch 27, 2023Leave a comment

The cybersecurity standard IEC 81001-5-1 focuses on how IT security needs to be taken into account in the software life cycle. As a special standard for health software, it supplements IEC 82304-1 and IEC 62304 among others, and can close gaps that urgently need to be closed. The EU is currently planning to harmonize IEC…

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