Medical Device Industry Assessment

Effective 28th February 2022, Platinum Shauffmantz Veritas Sdn Bhd (PSV) is no longer listed under Medical Device Authority (MDA) as a Conformity Assessment Body (CAB) due to we are in the mid of re-application our renewal registration. Due to this, PSV declared that;
  • PSV will not conduct any assessment for the Establishment under Act 737 2012 Medical     Device Regulations (MDRR) until got approval by the Medical Device Authority (MDA) and       further notice;
  • PSV will not be giving any advisory for any transfer process of certification for the        Establishment to ensure the Impartiality process of ISO 17021 are comply;
  • PSV will not use any certification marks, logo and trademarks of the Authority (MDA) that       carried as a Conformity Assessment Body (CAB);
    Any further notice and update regarding the matter above will be update accordingly.
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    ISO 13485 Medical Devices

    Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
    • Benefits

    Our future client's should implement ISO 9001 if:

    • There is a need to assess and show that the organisation is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
    • There is a need to demonstrate that the organisation can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.

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