Why do we get certified according to ISO 13485 and why is it important for you?
In our constant effort to improve, we are pleased to announce that we are well on our way to having ourselves and thus our quality management system certified according to ISO 13485. This expands our portfolio in software development to include the field of medical devices. As an ISO 13485 certified company, we can ensure that our software does not pose 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 sets requirements for the QM system of medical device manufacturers.And especially in the field of medical devices, it is important to be able to demonstrate a certified QM system. Only in this way can the effectiveness of the product and the safety of patients and users be ensured. Therefore, it is usually difficult to obtain a market approval for a medical device if such a QM system is not in place.
The process of 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 points of the standard. The QM system must be communicated, taught, and lived within the company. This is followed by an examination by a designated body or an accredited certification body.In the 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 reviewed. If the checks are successful, the certificate will be issued. This is followed by annual reviews and a re-certification is required every three years.
Often it is not enough if only the manufacturer of a medical device can demonstrate a certified QM system.
The development of a new medical product is no easy task. Therefore, it happens that individual parts of the development are outsourced.Reasons may be that work should be done faster and more efficiently, or because the required competencies are not available within the company.
But how can a suitable company be found? How should a manufacturer ensure that a company follows the same prerequisites and standards as their own firm? 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 can also demonstrate an ISO 13485 certified QM system. This can ensure that the development process is carried out with the same care as in your own company.This relieves the company itself, as it does not have to be checked again whether everything is carried out according to the guidelines. There is a regulated, documented process for all steps of development, in which the manufacturer can be sure that these are also adhered to. A basic trust can be placed in a company certified according to ISO 13485, which would otherwise not be possible.
A certification for you
For these very reasons, we at mediatec.net have decided to have our QM system certified according to ISO 13485.We would like to offer you the opportunity to outsource the software development of your medical device to a trustworthy, experienced and above all certified company. We want to provide you with the assurance that we exercise the utmost care in the development of your software and that there will be no complications in market approval.
It is important to us that you can entrust us with the software development of your medical product with peace of mind. Our goal is to offer you a worry-free collaboration.
Please feel free to contact us if you have any questions, or if you want to develop your medical product with us.
