ISO 13485:2016

Need of ISO 13485:2016 (MDQMS)

The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.


STARCERT UK LTD having the team of Auditor, Lead Auditor and Technical Experts who can conduct a value added Audit and contribute in the continual improvement of your organization.
STARCERT team can provide the two step audit and you are entitled for the certification of ISO 13485:2016 which is required by your customer or in tender purpose.


There are several Reasons to choose STARCERT as
  • 1. Value added two step certification process
  • 2. Timely delivery of certificate as committed
  • 3. 24 X 7 support as executive team is always available
  • 4. online processing from Application to certification decision
  • 5. Economical and Competitive Prices of Certification

Benefits Of ISO 13485:2016

  • 1. Increase efficiency, cut costs and monitor supply chain performance
  • 2. Increase access to more markets worldwide with certification
  • 3. Demonstrate that you produce safer and more effective medical devices
  • 4. Outline how to review and improve processes across your organization
  • 5. Meet regulatory requirements and customer expectations

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