01. THE CHALLENGE
Ensuring the performance and safety of medical devices is essential for delivering high-quality healthcare. If the equipment used by healthcare professionals does not provide accurate results in a timely manner, the consequences can be severe.
A Portuguese medical image-processing startup engaged Critical Software to support the certification of its image correction system as a Class IIb medical device. The company required a real-time solution capable of deblurring images used in arthroscopy procedures.
02. THE SOLUTION
Critical Software supported the certification of the image correction device by preparing all necessary evidence and assisting the company in producing the required artifacts in accordance with European standards.
The system’s Class B software classification under IEC 62304 required a rigorous approach to ensure CE marking (confirming the system’s suitability for use across EU member states). This involved carefully designed processes, gap analysis, and comprehensive documentation development.
Because parts of the certification process had already been initiated, a structured and methodical approach to project management was essential.
Key activities included a full system analysis and the development of certification plans to ensure compliance with standards such as ISO 13485, ISO 14971, IEC 60601-1, and IEC 62304. These standards define requirements for quality management systems, risk management, device safety, and software lifecycle processes.
Additionally, on-site audit support was successfully delivered, reinforcing strong collaboration between the client and the Critical Software team.
03. THE RESULTS
With Critical Software’s support, the startup was able to focus on enhancing the technical capabilities of its image processing system.
The clearly defined software development processes implemented during the project ensured efficient execution, ultimately reducing the system’s time-to-market.
04. THE ACTIVITIES
Verification & validation
Audit support
Intelligent video processing
Augmented reality (AR)
Documentation for compliance with ISO 13485, ISO 14971, IEC 60601-1, and IEC 62304