ISO 13485 in Malaysia

ISO 13485 in Malaysia - Medical Devices : Quality Management System

ISO 13485 specifies requirements in Malaysia 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.

Medical devices are required to meet certain regulations to be distributed to medical industries of Malaysia. A quality certificate that can assure you are producing and selling devices that are safe is the ISO 13485.

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.

ISO 13485 in Malaysia helps laboratories to develop or upgrade their Quality Management Systems in Malaysia. 

ISO 13485 in Malaysia is the leading ISO Consultants  handling Medical Devices and Quality Management.

BENEFITS OF ISO 13485 in Malaysia

  • Trust in being a safe supplier and producer
  • Likelihood of meeting customer requirements and expectations
  • Reduce operation cost and production loss rate
  • Improve processes based on objective measurement
  • Increase competitive advantage
  • More effective risk management
  • Better definition of roles and key responsibilities for employees

Note

1. Government Grant up to 90%* covering Consultancy, Training & Certification.

2. Check with us today! whether your company is eligible to apply for GOVT GRANT

3. If you are eligible, Get ready with these two basic documents, 1. ACRA / BIZFILE and 2.Financial statement. Let us prepare the rest of the documents, compile and assist you in Grant submission for 100% FREE

4. Contact our sales for the in Grant Application & claims process at 85993818 / info@isoconsultantsingapore.com

5. Our Consultants are experienced, locally certified and registered auditors. 

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