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Risk management for medical devices and ISO 14971 training – 2 days

07 - 08 mai
08:45 - 17:00

Oslo Science Park

The 2- day course has an integrated approach to risk management and is suitable for a range of different job roles within the medical device sector.

About the course:

This course will teach you how to work practically with risk management according to the requirements of the ISO 14971 standard. It covers all parts of the risk management process including Annex Z from the EN ISO 14971:2012 version of the standard, an orientation on ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-FMEA and FTA. It is a practical course with focus on how to do things, rather than just requirements or principles from the standard. The course will cover the upcoming ISO 14971:2019 changes.

Topics covered include:

  • The risk management process
  • Standards and general requirements relating to risk management
  • Risk analysis, evaluation and control
  • Risk management tools and techniques
  • Production and post-production

All participants will receive a printed handout of all the course documentation as well as an electronic course certificate which can be easily shared on social media including LinkedIn.

Read more about the course here.

The course is a 2 day course and will be hosted here in Oslo Science Park. The cost for members is NOK 7800 and for non-members NOK 9000. Meals and snacks are included. It will give you competence that can save both time and money in the future.

A minimum of 8 participants are needed to run the course, with a maximum of 12 participants. Members will be prioritized.

You are required to register at least 2 weeks before the event. Register your participation now! The registration is binding.

WELCOME!

Påmelding

Speakers

Peter Sebelius

Gantus - Peter Sibelius

info@gantus.se