Medical Device Training Malaysia

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Medical device training malaysia.

Regulations under the mda replaced the country s voluntary product registration. This course will give participants an in depth perspective and practical examples of the eto sterilization process such as validation standard eto routine process. Boston scientific medical device malaysia sdn bhd. Suppliers distributors manufacturers importer.

The association of malaysian medical industries ammi consists of leading medical device manufacturing companies in the medical technology industry. Medical device training courses learn how to design and develop medical devices to international quality standards such as iso 13485 how to meet and keep ahead of medical device directive regulatory requirements and gain knowledge of the ce marking process. Understanding the regulatory framework for medical devices in malaysia mda and mdaa. Passed in 2012 the medical device act mda and the medical device authority act mdaa represent the first efforts by malaysia to implement mandatory safety requirements for medical devices marketed or sold in that country.

Dqs certification m sdn bhd suite 43 4 setia avenue jalan setia prima s u13 s setia alam seksyen u13 40170 shah alam selangor darul ehsan malaysia. List of medical devices companies in malaysia. No matter the size of your organization sgs s medical device testing certification audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals. We provide training and certifications in diverse areas affecting the successful placement and competitive performance of medical devices in international markets.

Our expert instructors conduct practice oriented seminars and courses for professionals working in the medical device and technology industry. The training course is designed to create better understanding of the ethylene oxide eto sterilization process for the medical device manufacturing professionals in malaysia.