ISO 13485 Training on-site On-site 2-day training course Benefits of ISO 13485 QMS Standard content Implementation strategies ISO 13485 Implementation resources

ISO 13485 2003 On-Site Training Course

Who Should Attend This two-day training course is for Quality Engineers, Quality Managers, Documentation Management, Regulatory Affairs, and any other medical device manufacturing personnel involved in the maintenance of QMS for the ISO 13485 2003 standard.

Learning Objectives

Completing the course gives you an understanding and knowledge of:

• Format of the ISO 13485 2003 standard

• Relationship with ISO 9001:2000 and medical device regulations such as FDA 21 CFR 820, MMD 93/42/EEC and Canadian Medical Device Regulations

• Contents of elements and specific requirements for medical device manufacturers

• Approaches to developing documentation for the processes specific to ISO 13485 2003 standard

ISO Training Course Description

The training focuses on practical aspects of development and implementation of an effective ISO 13485 2003 QMS. It includes extensive group assignments with emphasis on development of efficient processes to support the requirements of the standard. For the course curriculum - click here

ISO training course materials include

• A copy of the presentation (produced by the client)

• Numerous templates of procedures required by ISO 13485 standard

• Three publications by the instructor related to quality management system for ISO 13485 2003 standard

For Instructor Qualifications Click Here

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