Software Development for a Regulated Environment
Our expertise in software development for regulated environments — including IVDR-compliant solutions — encompasses the consistent application of relevant harmonized standards: IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366-1 (usability). This enables our clients to achieve fast, cost-effective, and compliant market access.
Good to know:
The Regulation (EU) 2017/746 on In Vitro Diagnostics (IVDR) has been fully in force since May 2022. Manufacturers of device and analysis software are required to develop, document, and place their products on the market in accordance with the new, significantly stricter requirements. For existing products (legacy IVDs), extended transition periods currently apply until the end of 2027 and 2028 respectively — depending on the risk class. One prerequisite is an IVDR-compliant quality management system, which must have been in place since 26 May 2025. Anyone who has not yet taken action should therefore do so without delay.
Step-by-step to your IVDR-compliant solution
Our technical expertise stems not least from our well-established team of specialists from a wide range of fields, including IT, biology, mathematics, and food safety.
Whatever solution you need, we will get you there. We support you throughout all stages of the manufacturing process, from consultation through to validation. You can turn to us with confidence not only for new software development, but also when it comes to adapting or optimizing your existing software.
We look forward to hearing from you and to an open exchange about your specific challenges and needs.
