Our design process
To ensure that our devices can support Combination Product regulatory submissions in global markets, we have developed a design process which ensures that design controls are established from the outset. As well as a risk-based approach to device development, with appropriate stage-gates, we employ a rigorous, science-led, Quality by Design (QbD) philosophy to thoroughly explore the design space before we commit to our designs. This investment into understanding the parameters that affect critical quality attributes during the early stages of a project, mitigates risks during the later stages of technical transfer to manufacture, and leads to robust, approvable devices.
ISO 13485 certified
Our Quality Management System is certified by BSI to ISO13485 but has been designed to also comply with USA FDA 21 CFR 820 Quality System Regulation. Because it has evolved over nine years, the QMS reflects our working practices, and underpins every aspect of our work.