ISO 13485

Medical Devices Management System

Product Safety for Medical Devices by effective processes – First Plus`s certification helps you to design and manufacture high quality Medical Devices in order to ensure safety of patients and health care professionals.

What is ISO 13485 ?
ISO 13485 – “Medical devices – Quality management systems – Requirements for regulatory purposes” – is a comprehensive Quality Management System especially for the design and manufacturing of medical devices or their components. There are similarities with ISO 9001, however the focus of ISO 13485 is the product safety. Meeting the specifications for the products shall be ensured by efficiency of implemented processes. ISO 13485 contains requirements for the Quality Management System to fulfil customer requirements as well as regulatory requirements in markets worldwide.
Why ISO 37001?

Being certified to ISO 13485 provides many advantages to your business, as:

  • Certification according to ISO 13485 is the preferred method to prove  compliance with regulatory requirements.
  • Demonstration of development and manufacturing of safe and efficient medical devices
  • Monitoring of quality and performance during whole life cycle of medical products
  • Minimization and control of risks
  • Improve, document and standardize your processes
  • Increase access to markets worldwide
  • Increase customer satisfaction
  • Time and cost reductions