ISO 13485:2016

Medical Devices – Quality Management System

Standard brief

An ISO 13485:2016 certificate creates a global acceptance and reputation for companies in medical sector including manufacturers, storage, semi-finished product and service suppliers provides certification ISO 13485:2016 medical devices quality management system certification services. – medical quality management system with its experienced staff.  ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements.

Medical devices


  • Improve customer satisfaction.
  • Improve your processes.
  • Improve decision-making. 
  • Create a culture of continual improvement.
  • Better employee engagement.
  • Reduced cost of sales


  • Quality Management System.
  • Medical Device File
  • Design and Development Process of Medical device
  • Medical Device Life Cycle
  • Product Traceability – Medical Device Tracking
  • Software Integrations of the Medical Device  

ISO Certification

ISO 9001:2015

Quality Management Systems for all organisations of all sizes from all domains. Learn More

ISO 14001:2015

Environment Management Systems to ensure minimal environmental impact. Learn More

ISO 45001:2018

Occupational Health and Safety Management Systems for people safety. Learn More

ISO 22000:2018

Food Safety Management System to ensure safe food practices for your customers. Learn More

ISO 27001:2013

Information Security Management System for securing your organisation's information. Learn More

ISO 20000-1:2018

Information Technology - Service Management System to assist with smooth IT services. Learn More

ISO 13485:2016

Medical Devices - Quality Management System to ensure quality medical products.  Learn More

ISO 17025:2017

Requirements for Testing and Calibration Laboratories to demonstrate competent operations. Learn More

ISO 50001:2018

Energy Management System framework to manage and reduce energy use and costs. Learn More

Let's Work Together

European Assessment and Certification Ltd.
19, Layton Crescent, Slough, SL38DP, UK.
Company Number 12819256

+44 7471 048859

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