ISO 13485 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article that is intended by the manufacturer to be used alone or in combination.

Registration with ISO 13485 requires the manufacturer to implement an integrative management system which complies with the relevant regulatory requirements and evaluates all aspects of the company’s business process. ISO 13485 is pushing companies to change operating procedures which focus more on patient safety. Companies seeking international markets including India, the ISO 13485 is a prerequisite. Inability to acquire this certificate could result in loss in market share.

By achieving ISO 13485 certification, medical device manufacturers can hope to gain

  • Access to markets that recognize or require certification, including Canada, Europe and Asia
  • Decrease in operational costs
  • Increased customer satisfaction by delivery quality products
  • Proven commitment to quality
  • Increased transparency while dealing with product recalls, surveillance and handling

MDDI

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