MMD-125    Understanding of MS 2058:2018 Good Engineering Maintenance of
​                      Active Medical Devices
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• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This course is established to provide industrial support through competent regulatory training to industry, user and other authority for achieving requirements of Medical Device Act (Act 737) and Medical Device Regulation 2012 (MDR 2012).

This module is intended for participants who are responsible for maintenance, testing & commissioning, and disposal of a medical device in healthcare institutions and related facilities. It provides participants with essential information on medical device regulatory requirements and other relevant regulations besides covering the segmentation of standards pertaining to Medical Devices in Malaysia.   

At the end of the training, participants will be able to:

• Have an overview of the Medical Devices Act 737, and Medical Device Regulation 2012
• To provide the medical device regulatory requirements in a healthcare institute
• To enlighten on the importance of compliance with standards.

• Module 1: Medical Device Regulatory System in Malaysia
• Module 2: Overview of MS 2058:2018
  
• Module 3: Maintenance Management Principles
  
• Module 4: Implementation of MS 2058:2018 Requirements
  
• Module 5: Compliance, Risk & Best Practices
  

This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation.

This is a 1-day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.