13485 Certified – What Does It Mean For Your Business?


You’ve probably heard of the 13485 certifications if you’re a business owner. But what does it mean for your business? And is it something that you should be concerned about? So if you’re interested in learning more about the 13485 certified, keep reading!

What should I know about this?

13485 is an international standard that provides requirements for a Quality Management System (QMS) and is focused on medical device manufacturing. The 13485 ensures that medical devices meet all applicable regulatory requirements and safety standards and provide proof of compliance with the relevant regulations.

Not only does 13485 certify that a company’s products are safe, but it also helps businesses demonstrate that they have adhered to the highest levels of quality assurance throughout their production process. This can be beneficial when seeking approval from regulatory bodies or gaining access to new product markets.

We hope this information has been useful to you.