ISO 13485:2016 Introduction (Medical Devices)

by Spade Learning Academy Claim Listing

This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.

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img Duration

1 Day

Course Details

Description

This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.

All regulatory requirements are more stringent throughout each step of the products life cycle not limited to the servicing and delivery. As its functions varies its main purpose is to help and support international, national trade and businesses by developing standards that are recognised and followed worldwide.

Who should attend:

If you fall in any of the below stated groups, you should consider getting on this course:

  •  Instructor led Training (onsite at the company)

  •  Virtual Training

  •  In person (at our base)

  •  Regulatory Affairs Managers

  •  Internal and external Auditors

  •  Consultants

  •  Anyone involved with the implementation of the standard.

Key Course Topics:

  •  Introduction to ISO 13483:2016

  •  Standards relating to ISO 13483:2016

  •  The use of ISO 13483:2016 as basis for a QMS for medical device

  •  manufacturers

  •  Understanding the relationship between ISO 13483 and European

  •  Medical Device Directives

  •  The use of ISO 13483:2016 as the basic of regulatory

  •  requirements worldwide

Progression step:
Progression is a 'road map' for each individual, and each may progress at a different rate or take a different path to get to the next stage in their learning journey.  This course is the next step leading towards becoming an Internal Auditor for ISO 13485 (2 Day course).

Assessment Details:

  •  Continuous Assessment
  •  Open book 20 question multiple questions covering all topics in the course.

Course schedule:

Dates remain flexible please email or call one of our administrators to get available dates. 

Remote E-Learning:

All our learning can be carried out remotely therefore you do not need to travel miles just to get to college. You can receive the same quality of learning via our weekly webinars and online videos. Ours tutors are available to interact with questions and able to assist you to learn. We advise students to have access to: Computer/Laptop, Printer/Scanner, and access to internet.

Delivery Methods:

  •  Instructor led Training (onsite at the company)
  •  Virtual Training

Entry Requirements:

  • No previous or specialist knowledge is required. 
  • London Branch

    71-75 Shelton st,Covent Garden, London

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