Medical

New technology is quickly revolutionizing the medical sector, but whether it is a wearable medical device, a respirator pump or a smart hospital, they have one thing in common: lives of patients are at stake. As innovations progress, development time, cost and quality are important trade-off factors.

Secure and Safe

Medical devices interact with other devices and systems, which means protecting patient information is of top importance.By using test and validation tools, and tech stacks like a reliable data management system and secure network protocols, patient data is 100% protected.

Medical IoT

Medical IoT has drastically changed the medical sector. From wearable devices to track health data to a surgical robot. IoT is everywhere in the medical and healthcare sector. IoT creates big opportunities for companies in the medical sector, however with big opportunities, come big risks. Security and reliability in IoT are a critical element in the development of medical devices.

Compliance

The medical industry has stringent industry regulations and standards for patient safety and security. Strict laws and regulations means that requirements and traceability play a vital role in the development process of medical devices.

ISO certification

Meeting regulatory standards is one of the challenges medical technology developers face. Developing safe and effective medical devices requires a balance of effective requirements management, risk mitigation and automation.

We help developers of medical applications and medical hardware to organize a consistent development process for the entire product lifecycle up to the highest safety classification with future-proof embedded development solutions for medical software compliance.

• ISO 13485
• ISO 14971
• ISO 10993
• ISO 62304
• FDA Standards