Our ISO 13485 certification. Why is this important to you?

In an effort to continually improve, we are pleased to announce that our quality management system has been certified according to ISO 13485 certified . This means we are expanding our portfolio in Software development to include the area Medical products. As an ISO 13485 certified company, we can ensure that our software does not represent an obstacle to obtaining clearance or certification for your Medical Devices .

But what exactly is ISO 13485 and why is it so important for the medical device industry?

ISO 13485 is a standard that formulates requirements for the QM system of medical device manufacturers. And especially in the area of ​​medical devices, it is important to be able to demonstrate a certified QM system. This is the only way to ensure the effectiveness of the product and the safety of patients and users be ensured. Therefore, it is usually difficult to obtain market approval for a medical product if no such QM system is in place.

The process of a certification consisted of several steps. First, we established our new QM system. It was not enough to create the required documents and process all points of the standard. The QM system must be communicated, taught and  in the company lived . This was followed by testing by mdc medical device certification GmbH. This checked our documents and the company for certifiability . In the second step, the practical implementation and the effectiveness of the QM system checked. The auditor's check was successful and we were issued the certificate. Annual inspections now follow and a re-certification is required every three years.

 

It is often not enough if only the manufacturer of a medical device can demonstrate a certified QM system.

The development of a new medical product is not an easy undertaking. It therefore happens that individual parts of the development are outsourced . Reasons could be that you want to work faster and more efficiently, or because the required skills are not available in your own company.

But how can you find a suitable company? How should a manufacturer be sure that a company follows the same requirements and standards as its own company? How can work be outsourced without risking market approval?

The obvious and at the same time safest and easiest option is to choose a company that also has an ISO 13485 certified QM system. This allows to ensure that development is carried out with the same care as in your own company. This relieves the burden on your own company, as you don't have to check again whether everything is being carried out according to the guidelines. There is a regulated, documented process for all development steps in which the manufacturer can be sure that these are adhered to. A company certified according to ISO 13485 can be given a basic trust that would otherwise not be possible.

A certification for you

It is precisely for these reasons that we have had our QM system certified according to ISO 13485 by meddevs . We would like to give you the opportunity to entrust the software development of your medical device to a trustworthy, experienced and above all certified company to outsource. We want to give you the assurance that we will take the greatest possible care when developing your software and that there will be no complications with market approval.

It is important to us that you can entrust us with the software development of your medical device with a clear conscience. Our goal is to offer you a worry-free cooperation.

Feel free to contact us if you have any questions or if you would like to develop your medical product together with us.