Welcome to Easy13485

Easy13485 – your reliable partner for an ISO 13485 Quality Management System (QMS) according to the highest requirements!

Our customers know how important it is to operate and maintain a QMS that meets the strictest standards. With our Easy13485 service, you implement and document all requirements in a binding and verifiable manner. This way you can be sure that your company complies with the highest quality standards and that your products meet the regulatory requirements.

What does this mean for you as a customer? It’s simple – you can rely on Easy13485 to ensure that your products meet all the requirements of the Medical Device Regulation (MDR). Whether it is risk management, software development, IT security or usability – we cover all relevant areas and ensure that your QMS is fully compliant with the applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, EN 60601-1 and IEC 62366.

Our service offers you the security that the manufactured medical products meet the highest quality standards and that you stand out positively on the market. Easy13485 supports you in efficiently designing the QMS while always keeping an eye on the requirements. We are your reliable partner for successful certification and ensure that your company masters the compliance requirements without any problems.

Are you a medical device manufacturer?

What are you waiting for? Join our growing customer base today and convince yourself of the advantages Easy13485 offers you. Rely on our expertise and optimise your QMS for sustainable success!

Contact us now to learn more about Easy13485 and how we can help you take your QMS to the next level. Your success is our mission.


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ISO 13485

ISO 13485 is an ISO standard that represents the requirements for a comprehensive QMS for the design as well as the manufacture of medical devices.

How we can help

We explore the problem together and then draw up a plan.


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