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. 2024
  3. December
  4. 16

December 16, 2024


Maintenance and service of medical devices

By Prof. Dr. Christian JohnerDecember 16, 2024Leave a comment

The terms maintenance, preventive maintenance, restoration, inspection, service, and safety inspections are not synonymous. But they all refer to activities in the life cycle of medical devices that serve the objective of ensuring the safety, performance, and effectiveness of these devices even after they have been placed on the market. Manufacturers and operators must meet…

Details

Medical Writer: What this role must accomplish

By Dr. Anja KuhnertDecember 16, 2024Leave a comment

Medical writers have a firm place in the ecosystem of medical device and IVD manufacturers. This article clarifies

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