Distributing medical software
Our certification to DIN EN ISO 13485 standard qualifies us to assist you in the development of software that is classified as a medical device and to act as the distributor.
We are the partner who will accompany you throughout the entire product life cycle. We take on an advisory role as a supplier or even as a software distributor.
The conformity assessment procedure
It all begins with your first idea of the product and the resulting intended purpose. A conformity assessment procedure must be carried out once the applicable directives and the classification of a product have been established. The fundamental requirements to be met are determined and the strategy to prove their fulfillment is devised at this time. The selected conformity assessment procedure also determines whether the manufacturer needs to consult a “notified body” to establish conformity. In the case of Class I medical devices, the manufacturers themselves may declare conformity to the Medical Device Regulation. Higher class medical devices require consultation with a “notified body”, which may then review the design and manufacturing. This body must be accredited accordingly. In Germany, this is often done by TÜV.
The declaration of conformity
Since many elements, such as the technical documentation, must already be created during development, the procedure for conformity assessment must be embedded into the product development at an early stage. A clinical evaluation for each product is a mandatory part of a medical device’s conformity assessment as of 2010, when the new directive entered into force. In the simplest case, if the underlying data was obtained for a technologically comparable product with the same intended purpose, this can be based on existing literature. Otherwise, a clinical trial is necessary.
The declaration of conformity completes the conformity assessment. This is assurance that the manufacturer has considered and fulfilled all provisions applicable to the product, and can be specified with a CE label in the case of a physical device. The final step prior to distribution is product registration, for which the Federal Institute for Drugs and Medical Devices (ger: Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) is responsible. The product may then be distributed throughout the EU.
We are your certified partner
Our certification to EN ISO 13485 standard enables us take care of the conformity assessment and the entire distribution process on your behalf. We will support you throughout the entire life cycle of your software: from the initial product idea all the way to distribution, hosting, operation and maintenance.