ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for : Implementation of a Quality Management System with several enhancements. Risk Management approach to product development and product realization. Validation of processes. Compliance with statutory and regulatory requirements. Effective product traceability and recall systems. Access Filings offers ISO 13485: 2016 for Rs.25,999/-
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ISO 13485: 2016 Registration with Three Years Validity..
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ISO 13485: 2016 Registration with Three Years Validity..
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ISO 13485: 2016 Registration with three years validity & Trade Mark Registration..
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