Why are we certified according to ISO 13485 and why is this important to you?

In an effort to continually improve, we are pleased to announce that we are well on the way to certifying ourselves and our quality management system according to ISO 13485 let. We are thus expanding our portfolio in Software Development to include the area of ​​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. 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 consists of several steps. First, a QM system should be established. It is not enough to create the required documents and process all points of the standard. The QM system must be communicated, taught and lived within the company. This is followed by testing by a notified body or an accredited certification body. In a first step, the documents and the company are checked for certifiability. In the second step, the practical implementation and the effectiveness of the QM system are checked. If the tests are successful, the certificate will be issued. This is followed by annual inspections 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. The 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 can 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 at mediatec.net decided to have our QM system certified according to ISO 13485. We would like to give you the opportunity to outsource the software development of your medical device to a trustworthy, experienced and above all certified company. We would like to give you the security 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.