We combine our knowledge of regulatory requirements with a wide range of expertise in electronic product development, to provide you with a medical product fully certified and fit for market. Our key services in this sector are:
- Compliance with standards and regulations:
- Medical Devices Directive
- Risk management (ISO14971)
- IEC 60601 family of standards
- Product specific standards
- Software life-cycle processes (BS EN 62304)
- Design to the requirements of ISO13485
- Electronic product development
- Full verification and validation
- Production of the Technical File
- Liaising with the notified body of your choice during the approval process
- Multi-disciplinary product development
- Commercialisation of the state-of-the-art technologies
Xenon Delivery System
Datalink has developed the control and monitoring unit at the heart of the Neonatal Xenon Delivery System developed for Inspiration Healthcare with the purpose of Xenon treatment during the clinical trials.
The high cost of Xenon gas poses a significant engineering challenge in the application of this method; a challenge, which has been addressed by this design. The system benefits from an efficient, robust and reliable controller, accurately delivering Oxygen and Xenon through a patented breathing circuit to the baby, whilst maintaining their concentrations at the required levels.
Continuous Glucose Monitoring
Datalink developed the electronic control and measurement unit for the original version of the Continuous Glucose Monitoring (CGM) patch, a patented product developed by Nemaura Pharma for non-invasive continuous glucose monitoring.
Glucose monitoring helps people with diabetes manage the disease and avoid its associated problems. Continuous glucose monitoring provides a means of monitoring the blood glucose trends in individuals, helping them to better manage their condition and improve the quality of life in the medium and long term. The electronic module was designed to safely control the passage of a small electric current underneath the skin in order to initiate glucose extraction, measure the glucose level using the requisite sensitive analogue circuitry, and then transmit the result wireless to a handheld reader.