Quality Training

Quality Risk Management and ISO 14971

Objectives


This ISO 14971:2012 (Risk Assessment to Medical Device) training course is designed to provide attendees with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms.

Content includes

State the differences between the various revisions of ISO 14971 and the implications that these have for the manufacture of medical devices
  • Interpret the regulations pertaining to Risk Management and ISO 14971 in particular
  • Identify and quantify risks associated with medical devices
  • Decide on the acceptability of those risks
  • Re-evaluate risks following corrective action
  • Apply various risk assessment techniques such as FMECA, Fault Tree Analysis and HAZOP

Who should attend

R&D Managers and Engineers, Engineering / Technical / Production personnel, Quality Auditors

Upcoming dates:

No training dates available at the moment.

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Course

Quality Risk Management and ISO 14971

Training Days

1 day

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €200
* Cost quoted per person

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