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First Steps to Medical Device


Course Content:

  • Introduction & Course Objectives
  • An overview of the medical device sector in Ireland / Globally
  • What are medical devices and how do they work
  • Regulations that govern the medical device sector – ISO 13485:2016 and 21 CFR Part 820 and 93/42 EEC
  • How Medical devices are classified and brought to Market within Europe, USA and Canada
  • The role of Regulatory Bodies : Competent Authority – Health Products Regulatory Authority, FDA and notified bodies BSI,NSAI TUV etc – role within manufacturing
  • The role of Cleanrooms and classification of cleanrooms
  • Good Documentation Practice (GDP)
  • Work Instructions
  • Change Control
  • Good Manufacturing Practice.
  • Device Design Systems
  • Basic Problem Solving Techniques
  • Q&A
  • Conclude & Follow Up Process

This one-day course will be of interest to to individuals whom wish to work in the medical device environment or whom wish to begin medical device.


Classroom based, instructor lead, practical hands on course.

Product Description

This First Steps to Medical Device training course is a 2 Day programme, has been designed to introduce the trainee to understand the regulatory frameworks and infrastructure need to begin manufacturing medical devices


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