Medical Devices
Quality Management System
Requirements for regulatory purposes

Course length
1 day

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

Facts

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.
Contents	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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