Our Solutions tailored to your device
Quick links to our services
Our services are tailored to ensure your medical device, pharmaceutical products, diagnostic systems and software is evaluated in the optimal manner compliantly, efficiently, effectively and give you the satisfaction that any evaluation has been performed to the highest levels.
SUMMATIVE USABILITY STUDIES
HUMAN FACTORS VALIDATION TESTS
COMPARATIVE USE HUMAN FACTORS STUDIES
READABILITY STUDIES
Ensuring Quality in our Services
Performing our validation services to the highest levels requires consistency, attention to detail, rigour and process. This results in achieving deadlines, performing tasks efficiently and sticking within budgets. With over ten years of continuous improvement, our ISO 13485 certified Quality Management System delivers - for us but also for our customers. We are certified purely in Human Factors Engineering.
For each of our services, we follow internal processes that are continously being enhanced, to meet customer needs, but also to be 100% compliant to the required regulatory standards and regulations that are necessaey for smooth regulatory submissions but also to ensure the device, system or software is the best it can be - suited to the user, meeting their expectations, to be safe and effective.
Some of the standards and regulations we work to include:
For US submissions, for CE Marking, for submissions globally, compliance to these standards and regulations is often mandatory. If though, justifications, gap and threshold analyses are required to rationalize why there is usability equivalence between devices, we are expert in writing these. This is common with platform devices and systems which have known design differences. We also are flexible to work to customer Quality Management Systems to seamlessly aid auditing and internal document management.
Our Quality Management System also handles and controls all data and its security - from data collection through to document control to data storage. All aspects of how we collect and store data is vital for confidentiality and trust we have with our customers. We work to EU and UK GDPR requirements, US and UK Data Protection laws and ISO 27001 requirements where needed, as well as to our customer data needs. Collaborating and working with THAY Medical ensures data is kept secure in the optimal manners through a Quality Management System.
