ISO 13485: What You Need To Know

Clean Room 2.2ISO 13485 is valued by many medical device manufacturers throughout the world. This method was developed to create a management system on which to build compliance to various regulatory requirements. The requirements are not specific enough to contradict any country’s particular requirements, but to allow a company to demonstrate the ability to meet them.

Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on the management of risk in lieu of focusing on continual improvement. In order to achieve ISO 13485 certification, you must develop written policies for:

  • Document and record controls
  • Internal auditing procedures
  • Corrective and preventative actions
  • Process controls and validations
  • Traceability

ISO 13485 can help reduce surprises and failures that might damage a manufacturer’s reputation. It can be used as a tool to ensure the effectiveness of the quality management system. ISO 13485 also provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.

Hydrogel 2Some other benefits that manufacturers hope to gain from having an ISO 13485 certification are:

  • Gain more business and access to markets around the world
  • Increase customer satisfaction by delivering quality products and consistently meeting customer’s requirements
  • Guarantee the manufacturer meets all production standards and regulations for producing medical devices
  • Establish a manufacturer’s credibility and commitment to quality

Wilson-Hurd’s Advanced Technology Facility is proud to be ISO 13485 certified. We take great pride in the quality of your products and strive to be the most respected provider in the markets served. If you would like to learn more about what Wilson-Hurd can do for your medical device, click here.


About Wilson-Hurd:  Wilson-Hurd Manufacturing specializes in the production of custom electronic control products, point-of-purchase displays, medical contract manufacturing, printed electronics, as well as nameplates & dials, overlays, and panels. Wilson-Hurd was founded in 1904, and is headquartered in Wausau, WI, with additional locations in Berlin, WI.

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