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Services

  • Certification Transfer
  • GDPMD Certification
  • ISO 13485 Certification
  • ISO 9001 Certification
  • Full Conformity Assessment
  • Product Verification
  • Aesthetic Personnel Certification

Certification Transfer

Transferring your certification to us is simple. If you hold accredited certification with another body and you decided to make the move, we will ensure the transfer is as smooth as possible.

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GDPMD Certification

Regulatory requirements for medical device safety & performance. It shall be implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian Medical Device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737).

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ISO 13485 Certification

Quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities.

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ISO 9001 Certification

International standard that specifies requirements for a quality management system. The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and meet customer and applicable statutory and regulatory requirements.

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Full Conformity Assessment

A systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices.

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Product Verification

The product conformity assessment by way of verification is a process to verify the manufacturer's qualification, pre-market approvals by the Malaysia Medical Device Authority's recognized countries regulatory Authority.

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Aesthetic Personnel Certification

The program focuses on the theoretical aspect encompassing the science of aesthetics and the application of evidence-based practice, assessment and management of clients presenting with aesthetic problems. In addition, supervision and training is provided by Aesthetic Medical practitioners and certified senior aestheticians in the field of aesthetic.

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