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ISO 14971 Training

Our training program covers ISO 14971:2019 which outlines a framework for applying risk management to medical devices. It emphasizes identifying, evaluating, and controlling risks throughout a device's lifecycle, ensuring patient safety. The standard guides manufacturers in making informed decisions, balancing benefits and risks, and complying with regulatory requirements to enhance healthcare outcomes.

Anchor ISO 14971

Course Objectives

At the end of the presentation participants should be able to do the following:
•    An expert with knowledge of the requirements, terminology, principles, and process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.

•    Highly competent and qualified company personnel in implementing and applying risk management processes to all phases of the life cycle of a medical device within the certification scope.


 

Course Outline

Set the State- Overview:


•    Ice breaker- Recognizing and Identifying the        importance of risk management systems for medical devices.
•    Objectives of the workshop
•    Agenda
•    Administrative arrangement


Session 1: Overview of Risk Management System for Medical Device


•    Introduction of ISO 14971:2019
•    Overview of ISO 14971 and 
•    Briefing on each clause of ISO 14971:2019
 

Target Audience

This program is very useful to participants who handles and are actively involved in Quality especially those who are QA/QC Lab technician, and QA/QC Executive.

Duration

1 full-day course running from 9.00 am to 5.00 pm. Physical Training (On-site).

Training Fees

RM10,000 per session. Max of 15 pax per session. Additional RM700 for the subsequent participant (logistics and refreshments are excluded).

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