Modular components make it easier for developers to coordinate hardware and software and implement European regulations such as MDR and IVDR
Regulatory Affairs, Regulatory Certifications
Information
The introduction of Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] has made the development of medical devices significantly more complex. For manufacturers, this means more effort – especially in terms of documentation and product certification, even for existing systems. Solectrix meets this challenge with modular individual systems.
Medical devices based on the modular principle
Every device begins with a precise analysis of similarities and differences. Laboratory devices, for example, often share the same requirements for sample processing. The evaluation method varies, but operation remains intuitive – combined with cloud and clinic integration.
This is where the modular system comes in: reusable modules save development time, reduce effort and ensure the highest quality. Each ‘building block’ is fully specified, developed and verified at Solectrix.
Efficient development thanks to ALM
With PTC's codebeamer application lifecycle management system, information can be transferred to new projects almost by copy and paste. Integrated protection and control mechanisms guarantee complete traceability – from the initial idea to the finished medical device.
