ISO 13485:2016

Medical Devices Quality management systems

ISO 13485 is a Quality System for Medical Device and adopt a risk management approach to identify risk throughout the medical device product realization and such identified risks are managed to eliminate hazardous situations in medical device.

It not only addresses the regulatory requirements applicable for medical device realization but also for device specific and customer specific requirement that have potential adverse impact and risk on the product.

Any organization who adopt  the standard, the clause of the standard clearly define and require how the  regulatory and customer specific requirements are addressed.

Medical Device Manufacture also reduces trade barrier to enter into international market.. This Certification is voluntary, even, adopting and obtaining it allows medical device manufacturer to meet Quality System requirement of European Medical Device Directives , Vitro Medical Device Directive  and Active Implantable Medical Device Directive .

Benefits :

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of your supply chain
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements