ISO 13485:2016 Certification

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.


PCMS Role in ISO-13485 Certification

PCMS having the team of Auditors and Technical Experts who can conduct a value added Audit and contribute in the continual improvement of your organization. PCMS 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.


Benefits of ISO 13485:2016 Certification

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