Industry Expert Learning Series HRDF SBL Claimable
Code of Practice for Good Engineering Maintenance Management of Active Medical Devices (Malaysian Standard MS2058 : 2009)
DURATION : 2 days INTRODUCTION The new Medical Device Act 2012 (ACT 737) has been gazetted in the year 2012 and officially started its implementation on 30-June-2013. Section 43 of the ACT 737 require that respective stake holders shall be held responsible and liable in ensuring all medical devices are safe for use. For the active medical device, this “Malaysian Standard MS 2058:2009”, applies to all active medical device placed for use in any healthcare facilities or any other facility which requires maintenance. This standard is the “Code of Practice”, governed by the Medical Device Authority, Ministry of Health Malaysia. Clause 28 of “Good Distribution Practice for Medical Device (GDPMD), MDA/RR No 1: July 2013”, required to implement this MS 2058:2009.
COURSE OBJECTIVES The course provides participants essential information on the requirements of MS 2058:2009, which is crucial for all active medical devices to ensure the device safety and performance in accordance with its manufacturer’s requirements and declaration; and “Malaysian Statutory and Regulatory Requirements. Biomedical Engineering Personnel”” play the major role in order to achieve these objectives. This standard emphasizes the competency of the biomedical engineering personnel, who are mainly responsible for the technical related issues. On the other hand, the owner and user must be aware of these requirements to ensure all active medical devices are in safe hands.
Understand the importance of MS 2058:2009
Nature of active medical device life-cycle and maintenance throughout its entire life-cycle.
Nature of technical requirements throughout its entire life-cycle.
The roles of biomedical engineers in terms of their competency levels.
The technical requirements depends on these roles.
Future plan for biomedical engineers in Malaysia.
TARGET AUDIENCE All biomedical engineers, technicians, managers and their top management, management of healthcare organizations and institutes AND management of medical device supply chain industries
iNTERESTED TO FIND OUT MORE? For enquiries, please email to email@example.com. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347