Medical Devices

Medical Devices must be precise and safe. Users, patients and third parties must be able to rely on their safety and performance. Otherwise, there is a risk of serious injuries or recalls with the corresponding loss of sales and reputation. We meet this challenge with a cross-functional team of product management, regulatory and technology experts.

While other companies are locked into one technology, we select the right technology based entirely on the purpose and target group(s) of your product. Our approach is also oriented towards your unique needs. If you have a development team and only need support in individual roles, we can provide you with either individual experts or a team. In the case that you want to completely focus on the product or hardware, we act as a key partner for your medical software.

Even after CE certification, we are happy to assist you with the further development of your medical device and with regulatory expertise.

The spectrum of medical devices that contain or consist of software is very broad. However, development challenges are often comparable. These are the scenarios in which we can come into the picture:

• A new medical device is in development, so an ISO 13485 certified medical software provider is needed.
• A medical device is already in use; however, the existing software needs to be replaced with state-of-the-art software.
• An existing medical device is assigned to a higher risk class due to new functions; accordingly, new requirements must be met.
• A company wants to launch a new product as a digital health application according to § 139e SGB V and needs a partner to accompany the development and approval.
• An existing development team lacks the resources to develop a product in the specified time. They need reinforcement in project management, development, or regulatory affairs.

You are planning to bring a new medical device to market or to adapt or expand an existing medical device? We accompany you step by step: from the definition of the intended use and the definition of requirements to the standard-compliant software development to the CE certification and further development.

This can be standalone software, embedded software - the application for your medical hardware - or the new interface between already existing systems. Depending on your individual situation, we act as a key provider for your software or support your development team with the required roles.

In the project itself, we first ensure that the entire team has a common understanding of the product, the target groups, the requirements, and the risks. With this knowledge, we define the regulatory scope. In doing so, the requirements for the medical device are derived from the risk class, including the scope of the documentation to be provided, the provision of a certified quality management system, the need for studies or the commissioning of a notified body. We then select the right technology and approach to develop the customized software for your medical device.

As a developer and supplier of medical software, we are ISO 13485 certified and auditable.