This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic).
ISO 13485 is suitable for all the organizations involved in the medical device lifecycle and looking for an improvement in the way it is operated and managed. In recent years, ISO 13485:2003 has become the worldwide reference standard for the companies dealing with medical devices.
ISO 13485 certification
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