Medical Device Electronics & Software Development
Developing successful medical systems for demanding applications takes a high level of expertise and a rigorous approach to quality. With over 100 years combined experience in the development of embedded systems, electronics and software for medical imaging, diagnostic and monitoring equipment, Tactiq brings a breadth and depth of experience to take on the most challenging projects. Our experience in developing medical devices and with standards such as IEC 62304, IEC 62366, ISO 14971 and IEC 60601 ensures regulatory compliance for even the most demanding medical devices. Our team is particularly experienced at managing projects in this highly regulated industry. Along with ISO 13485 accreditation we have proven capabilities to take on complete systems with our expertise in system design, electronics, software and user interface design.
Our highly qualified engineers include members of the Institute of Physics and Engineering in Medicine (IPEM), the Institute of Engineering and Technology (IET) and PhD qualified engineers.
Tactiq is proud to have GE Healthcare as one of our major clients who we have supported for over ten years including a leading role in developing and supporting their most successful Nuclear Medicine imaging system. Tactiq serve a number of healthcare clients with products ranging from portable medical devices to telemedicine systems. We work with luminaries and specialist hospitals which provide an invaluable source of expertise, product feedback and trials environments.
Tactiq's experience and expertise in embedded software, electronics and user interfaces for medical systems enables us to quickly assess projects and produce an early design concept. This top level architecture allows us to perform modelling and simulation to identify potential issues early and give confidence in both architecture and performance. For user interface development, we have in-depth knowledge of User Task Analysis techniques to ensure the user's needs are clearly understood, combined with the software skills to rapidly develop solutions that make complex systems simple to use.
The regulatory demands on the development of medical software can be very tough. Tactiq has experience developing medical embedded and UI software ranging from medical class A (low risk) to Class C (high risk). A thorough understanding and experience of applying the FDA/CE requirements and the standards such as IEC 60601 (medical devices), IEC 62304 (medical software), ISO14971 (risk management) and IEC 62366 (usability) are vital to get first time approval and avoid extra work. Knowing how much and how little documentation is required and guidance on how to classify the safety levels will save a lot of unnecessary work.
As well as Tactiq testing, verifying and supporting validation of software we develop, we also offer this service to software developed by our clients or third parties. Often clients have developed the software or have had the product on trials for a while but do not have the experience and resources to fully test and verify this against the regulatory requirements. It is also extremly valuable to get a third part to assess the software as this almost always gives new insight and highlights new issues. Tactiq can cover the full range from reviewing the requirements and design, writing the test procedures, developing test software, testing, verification and report generation. We can also modify the software in line with our recommended changes if required.
Tactiq project managers and engineers have planned and executed projects with client teams around the world including the USA, Israel, Asia, Scandinavia and mainland Europe. We have a flexible approach to projects which means we can integrate fully with a client's project team or drive the project more remotely. Whichever way the client wishes to structure a project, we always ensure it is a total team approach with close, trusting communications and regular face to face meetings at key project phases.
Tactiq's ISO 13485 accreditation and adherence to robust quality systems are a way of life for us when developing systems for critical application environments such as healthcare. From initial proposals, through design, certification and in-field support, Tactiq have proven quality disciplines that ensure the highest standards are kept throughout. Having quality as second nature also provides additional benefits such as more efficient development projects, design optimisation and overall performance improvement.
Tactiq has an impressive track record in embedded medical projects covering software, electronics and user interfaces: some example case studies are shown below.
"Every 5 seconds a patient is imaged using technology developed by Tactiq"
Medical Imaging Systems
Healthcare Regulatory Approval