ISO 13485 : 2016

This course is an ISO 13485 for Medical Devices general orientation course for personnel.

  • ISO 13485 - The international quality management standards focus on the requirements for medical devices manufacturers, the basis for USA FDA requirements and is required by Canada under their CMDCAS program. This international standard has been adopted by Europe as EN ISO 13485 European standard for CE Marking.
  • EN 46003 - The European quality management standards focus on the requirements for medical device manufacturers. Widely used as the basis of CE Marking certifications,
  • EN 46003 is applicable to those manufacturers needing only product quality assurance certification.

Business Benefits

  • Explains the benefits of ISO 13485
  • Explains how the quality system works
  • Instructs personnel how to use the system
  • Reviews the requirements of the standard
  • Helps personnel to prepare for the certification audit

Course delegates will be able to as a consequence of this course:

  • Be aware of the aims and objectives of ISO 13485
  • Understand the ISO 13485 System content.
  • Interpret for application purposes the ISO 13485 standard.
  • Identify the need and create any additional processes and procedures reflecting the ISO 13485 standard.
  • Coherently answer questions regarding the ISO 13485 Standard

Who Should Attend?

  • Quality Professionals, Senior Management and Staff wishing to introduce ISO 13485

Course Structure

Items covered include:

  • ISO 13485 Standards
  • ISO 13485 Systems Assessment
  • ISO 13485 Systems Documentation
  • ISO 13485 Planning

Course dates and cost


Get in touch to arrange a free initial meeting or to find out more