close

Our Phone Number +353 (0)61 514 744

Our Email info@OptimaTraining.ie

ISO 13485:2016 Medical Device Standard

Live Webinar

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

If more than one separate with a comma

295.00

Make an Enquiry
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

This course 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.

Classroom based, instructor lead, practical hands on course.

Product Description

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.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours