ISO 13485

Medical Devices
Quality Management System
Requirements for regulatory purposes

Course length
1 day

Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)



Background ISO 13485 – Requirements for Quality Management System for regulatory purposes
Scope The participants will gain knowledge about the ISO 13485 . All basic requirements will be discussed.
Intended for All personnel in the medical device industry.
Qualifications None specific. Knowledge about previous issue ofaquality management system is beneficial but not a requirement.
  • Background of ISO 13485
  • Structure and requirements
  • News and coming changes (TC210 WG1)
  • Questions and answers
Program In-house training course.

No of participants

Maximum 16 persons
Qualification test Written test may be included – if desired
Documentation Course file


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