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ISO 13485:2016 – International Medical Device QMS Standard

NSF International, Health Sciences
Course summary
2 hours
400 USD excl. VAT
English
Online courses
Next available date: Enquire about this self-paced eLearning course - Online courses

Course description

ISO 13485:2016 – International Medical Device QMS Standard

This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device quality management system (QMS) regulations around the globe. This course covers the goals of the standard and in-depth instruction regarding Clause 4-QMS; Clause 5-Management Responsibility; Clause 6-Resource Management; Clause 7-Product Realization; and Clause 8-Measurement Analysis and Improvement.

Outcome / Qualification etc.

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

Training Course Content

By the end of this course you should be able to:

  • Define the primary purpose of ISO 13485:2016
  • Identify the general and documentation requirements of a QMS as outlined in Clause 4
  • Recognize the responsibilities of management within a QMS as outlined in Clause 5
  • Identify the resources needed to implement and maintain an effective QMS; and meet regulatory and customer requirements as outlined in Clause 6
  • Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
  • Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Course price: $399.99

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International, Health Sciences

NSF International provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are...


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Contact info

NSF International, Health Sciences

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

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