ISO 13485 MALAYSIA (MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEM)
ISO 13485 – Malaysia requirements for a Quality Management System that can be used by an organisation in Malaysia involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning, disposal of medical devices, and provision of associated activities in Malaysia.
Internationally recognised and accepted, the ISO 13485 is a necessary certification in Malaysia if you are looking to improve performance and remove any uncertainty in your business. Suitable for medical device industries, this certificate requires you to specific requirements.



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Brochures
View our 2020 ISO 13485
brochure for an easy to read guide on all of the services offer.