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Medical Devices

Customized and standards-compliant software

Innovative and reliable products that bring value to your patients and HCPs

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.

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Challenges in medical device development

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.

Our Success Stories

  • Point-of-Care Diagnostics

    Lab Equipment Software

    With a team of biotechnology, MDR/IVDR and technology experts, adesso provided user software for a laboratory analysis device. The device has been successfully launched in more than 30 countries and is continuously maintained and further developed by adesso. PDF Download

  • Software as a Medical Device

    Hardware management and therapy monitoring

    A medical technology manufacturer developed an inhaler for the use of medical cannabis. adesso designs and develops several mobile medical devices, via which the device is remotely controlled by the physician and the patient's therapy can be monitored. Contact us

  • Software as a Medical Device

    Thieme – Digital medical history and consent

    adesso supports Thieme Compliance in the development of a mobile application that improves the quality of patient medical history assessment, information and consent before medical procedures, thereby reducing the time and effort required for patients and practitioners Contact us

From consulting to software development to validation - we offer the 360 ° approach

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.

Our Certificate
  • Workshop to precisely define a product idea (Interaction Room/Design Thinking)
  • Correct and precise formulation of the intended purpose and the intended use
  • Production of a prototype and customized designs
  • Examination of technical feasibility
  • Target group definition and market research
  • Determination of the (software) risk class
  • Analysis, documentation, agreement and management of all needs and requirements
  • Risk analysis, risk implementation and risk assessment according to ISO 14971
  • Preparation and update of all necessary SOPs and specifications
  • Validation of tools and processes
  • Creation of all necessary documents required for CE certification
  • Development of user manual
  • Software development of the medical device as well as further systems for reimbursements and complaints according to IEC 62304
  • Creation of MVPs for clinical testing / usability testing
  • Support for product audits
  • Test management and testing according to IEC 62304
  • Consulting and support in the development of AI products
  • Establishment of a quality management system (QMS)
  • Tool selection and configuration for technical mapping of the QMS
  • Training of employees in the use of medical devices
  • Support in the development of processes and documents for audits
  • Gap analysis and derivation of interventions
  • Creation of the QM manual

Do you have any questions?

No website or brochure can ever trump a face-to-face discussion about the goals and issues that are relevant to you. We look forward to meeting you in person. Get in touch with us!


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