There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.
ISO 13485 is a standard that provides specific requirements for the application of ISO 9000 to the medical devices industry for regulatory purposes.
This standard help to ensure the consistent application of quality requirements in this industry, they are being applied as part of the regulatory regime for medical devices in a number of countries.
Konsultan ISO 13485
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