ISO 13485 adopts the risk management approach where to identify the risk involved throughout the production cycle and that risk to be managed to eliminate the hazardous elements in medical devices.
Designing, manufacturing, installing, technical assistance and sales throughout different phases of medical devices life cycle ISO 13485 certification guarantees the conformity to International standard. Post-production aspects such as storage, distribution, provision of associated services Quality Management System covers the post-production process as well. ISO also regulate the disposal and decommission of used and damaged medical devices.
For more information and updates in the ISO 13485 certification, keep an eye on the URS website.
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