Technocom Systems Sdn Bhd certified to ISO13485:2003
ISO13485:2003 supports the reduction of risk with regard to usage of medical devices. This holds not only for companies that design, construct, produce and service medical devices, but also for organization distributing and using them. The standard aims to increase the organization's reputation in the eyes of customer and authorities.
In the face of these risks, and with the specter of the penalties suffered by the medical device industry, it is clear that every medical device manufacturer must have a complete understanding of the legal risks inherent in the sales and marketing of medical devices. Compliance to ISO13485:2003 is the first step a manufacturer can demonstrated they have a sophisticated knowledge of reimbursement policies, know how to implement and maintain effective compliance guidelines, and monitor ongoing enforcement activity in the industry. They must do all these things while supporting the achievements of aggressive sales targets. This is why in the medical device industry, things are never so simple.
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