• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
• Manage risk effectively
• Improve processes and efficiencies as necessary
• Gain a competitive advantage

1. PAN Card

2. GST Certificate / MSME

3. Minimum two Purchase bills

4. Minimum two Sales Bills

5. Declaration

6. MOA, AOA and Incorporation Certificate (If Company)

7. Other documents as required

A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar article, that is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions. There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include simple devices like wound dressings and scalpels ; durable devices like wheelchairs and dentist chairs ; implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints ; life-supporting devices like respirators and lung ventilators ; sophisticated, software-controlled devices like CT scanners and MRI machines; and in vitro diagnostic reagents and test kits

All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards, including the new edition of ISO 9001.