| Who we are |
Our focus is making the world a more user-friendly place.We help you take care of human factors and usability for medical device design, development and verification. We help you understand the requirements of international standards and regulations, guiding your device development to achieve and maintain compliance. We help companies, the public sector and other organisations to design, develop and launch successful medical device and device/drug combination products, by turning the spotlight on Human Factors and Regulatory Factors. We've seen the harm that results when either topic is neglected until the latter stages of product development, through our many years of experience in pharmaceuticals and medical device development. The most powerfully successful projects we've been involved with factored in both the Human and Regulatory aspects right from the start, so we've seen the tremendous benefits of getting this right. We passionately believe in the value of building Human and Regulatory Factors into projects from their very early stages. It has surprised us how often ideas for new medical devices or products are developed before finding out if patients and health care providers need them. We work with organisations to clarify, test and refine their ideas with specific user groups. Over this we lay the expectations of regulatory authorities, to build a development history that supports your submission. |