Our  ISO 13485:2016 (Medical Device Standard) programme is also available for delivery as a Customised In-Company Course at clients’ facilities nationwide in Ireland, including Dublin, Cork, Limerick, Waterford, Galway and Sligo at very competitive rates. 

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Course Contents:

Introduction to ISO 13485:2016

· Structure of the standard

· Contents and purpose of each section

· New Revision: ISO 13485:2016

· Major changes from the previous revision

· Correspondence to and differences between ISO 9001:2015

· CE marking implications

Overview of the standard

· Process approach

· Quality management system

· Requirements

· Resource management

· Product realization

· Measurement, Analysis and improvement

Audit Exercise using the standard

· Attendees will break into groups and carry out an audit of a specific area of the facility.

· This will require prior preparation within the facility.

· Afterwards the groups will convene to share experience.

· Responding to an Audit

This ISO 13485:2016(Medical Device Standard) training programme may be beneficial to Quality Engineers, Quality Managers, Documentation Management, Regulatory Affairs and any other personnel in medical device manufacturing industry who must adhere to the ISO 13485:2016 standard.