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ISO 13485:2016 Medical Device Standard

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ISO 13485:2016 Medical Device Standard

This ISO 13485:2016 Medical Device Standard training course is a 1 Day public programme, designed to provide attendees with a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485. This ISO 13485:2016 Medical Device Standard training course may be beneficial to any personnel in medical device manufacturing industry who must adhere to the ISO 13485:2016 standard.

17/02/2025

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295.00

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Iso,Standards,Quality,Control,Assurance,Warranty,Business,Technology,Concept.

Course Content:

  • Introduction & Course Objectives
  • 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
  • Q&A
  • Conclude & Follow Up Process

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