2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

Good Engineering Maintenance Management of Active Medical Devices Onliine Training

MS2058:2018 Good Engineering Maintenance Management of Active Medical Devices

INTRODUCTION

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.

 

 

Course Objectives 

  • To provide 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.

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Course Outline 

 

  • Overview of Medical Device Regulatory System in Malaysia (Pre-Market, Placement on Market & Post-Market) 
  • Interpretation of MS2058:2018 Good Engineering Maintenance Management of Active Medical Devices
  • Auditor’s Expectation based on MS 2058:2018
  • Group Discussion & Workshop
  • Q & A session

How you learn?

Course Approach

Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback.

 

 

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Frequently Asked Questions

Who should attend?
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Biomedical Service Provider/ Biomedical Engineering Trainers/ Biomedical, Mechanical, Mechatronics, Electrical, Electronics Engineering graduates/ Technical and Vocational/ Education and Training (TVET) / BEM and FEM Managers/ Interested Individuals
Can I participate if I don't have the basic knowledge ?
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Not to worry! In a class, there are different levels of knowledge and understanding of the students. Our trainer will assess the level of each student before the class starts, and will adapt to accommodate everyone. Additionally, there will be a Q&A session to address any questions or concerns.
Can I get a package discount price if more people join?
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Yes, if more than 5 people from the same company join, they are entitled to receive a 10% group discount.

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Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

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ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

A Simple Image
A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.