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Independent Audit for Food Industries
We conduct food safety such as FSSC 22000 and our quality audits are used widely in the food industry, namely to evaluate management systems, obtain certifications to ascertain food safety and quality standards, assess the condition of premises and products, and confirm legal compliance.
Full Conformity Assessment
Full conformity assessment is a solution designed to ensure that the medical devices meet the standards set by the Malaysian Medical Device Authority. We can help manufacturer and distributors of medical devices to register their products with the Malaysian Medical Device Authority especially those with medical devices without the recognised pre-market approval.
Good Distribution Practice for Medical Devices (GDPMD)
This is a regulatory requirement for medical device safety and performance. The law requires qualified agents to implement and maintain the carrying out of activities in medical device supply-chain in Malaysia to comply with the Malaysian Medical Device regulatory requirements as stated in the Medical Device Act 2012 (Act 737).
Product Verification
We conduct Product Conformity Assessment by way of verification to ensure that medical devices meet the specific requirements set by the Malaysian Medical Device Authority.
ISO 13485
An accredited ISO 13485 certificate creates a global acceptance and reputation for companies in the medical field which includes medical device manufacturers and distributors. This is a quality management system that can be used by an organization involved in design and development of medical devices or production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities. We have a team of experienced personnel to ensure we provide a systematic service that consistently meets our customer's requirements and regulatory requirements and safety standard. We value add our services with post market follow up and complaints handling including surveillance and product recall handling.
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