A clear development process to ISO 13485
Our design and development process for medical devices is certified to ISO 13485:2016 by LRQA. It’s a process created to enable all project stakeholders to easily see, what needs doing and when. It’s used from our very first client meeting until our involvement in the project is complete. It’s been designed to be a highly visual document, so a project’s requirements are explicit and all in one place from the outset. Our clients quickly understand they can enter or leave at any phase or stage of the process and we can work within your own design controls or QMS too. We are highly flexible and adaptable so you can use us for one or two specific services or a full device development project, the choice is always yours.
We capture our research, ideas, potential risks, meeting notes and any key decisions as a project evolves. This provides clear evidence of the work done and ensures a design’s robustness when it goes through engineering. It enables stakeholders to quickly understand the background to designs as they progress through from Concept, Prototype Development and on into Design for Volume Manufacture.
Our background and business structure require us to be lean and efficient with our time. We therefore have lots of techniques and systems which cut through a lot of the waffle surrounding the development process to ensure projects are delivered on time, to budget and compliant with regulatory requirements.
If you are encountering difficulties, need expertise, resource or have a problem to solve then please give us a call, we will always try to help.