ISO 13485

Medical Devices – Companies trust EAGLE to ensure their management systems improve the quality, reliability and cost effectiveness of their medical devices in the global marketplace.

Why ISO 13485 Certification?

Doctor with an x-rayManufacturers who achieve certification to  ISO 13485 bring confidence and assurance to their clients, stakeholders and themselves. Being certified establishes a set of standardized processes to help produce safe, quality products. It also facilitates a proactive risk management system to detect and prevent product defects.

Manufacturers benefit from ISO 13485 certification by:

  • Expanding their market by giving them the ability to work in countries where certification is a prerequisite
  • Improving customer satisfaction as a result of standardized processes
  • Improved traceability and risk management
  • Providing a common quality system approach in the supply chain for supplier and/or subcontractor development and consistency
  • Helps place manufacturers more in line with quality principles
  • Enhancing their company image by demonstrating a commitment to quality that is proven through certification

Contact us today to start the process.

What is ISO 13485 Certification?

ISO 13485

ISO 13485 certification is an internationally recognized standard that helps medical device manufacturers and suppliers improve their FDA and regulatory compliance. It focuses on what the manufacturer does to deliver safe and effective medical devices.

The standard merges ISO 9001:2015 with the medical device GMPs by incorporating additional requirements of:

  • Cleanliness of product and  installation and servicing activities
  • Particular requirements for sterile medical devices and validation of processes for sterilization and sterile barrier system
  • Software validation
  • Patient risks
  • Supplier agreements
  • Equipment qualification