Why do we get ISO 13485 certification and why is it important to you?

In our efforts to constantly improve, we are happy to announce that we are well on the way to certifying ourselves and our quality management system according to ISO 13485 to let. We are thus expanding our portfolio in software development to include medical devices. As an ISO 13485 certified company, we can ensure that our software is not an obstacle to obtaining approval 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 field of medical products, 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. It is therefore usually difficult to obtain market approval for a medical device 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 work through all the points of the standard. The QM system must be communicated, taught and lived in 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 reviews and a re-certification is required every three years.

Frequently, it is not enough if the manufacturer of a medical device alone can show a certified QM system.

The development of a new medical product is not an easy undertaking. Therefore it happens that individual parts of the development are outsourced. Reasons can 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 a suitable company be found? How should a manufacturer ensure 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 ensures that the same care is taken during development as in one's own company. This relieves your own company, since it is not necessary to check again whether everything is being carried out according to the guidelines. There is a regulated, documented process for all steps of development, which the manufacturer can be sure will be followed. A basic trust can be placed in a company certified according to ISO 13485, which otherwise would not be possible.

A certification for you

Precisely for these reasons, 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 want you to have security that we will take the greatest possible care in the development of your software and that there will be no complications when it comes to market approval.

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

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

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