In an industry where patient safety and regulatory compliance are non-negotiable, making unverified or misleading claims isn’t just bad practice – it can lead to hefty fines, product recalls, and serious reputational damage.

Guided by Hardian Health’s regulatory expertise, UCL spin-out Guildford Street Laboratories (GSL) has achieved a landmark milestone with their blood-based test, PD Predict, receiving FDA Breakthrough Device Designation

In part 1, we outlined the key concepts of a quality management system (QMS), explored what a QMS is – and what it is not – discussed why a QMS is required by law and who needs it, and provided an overview of the structure of a QMS. Now, in part 2, we'll move on to the practical side of implementing and managing a QMS effectively. Now then, back to Kipling’s six honest men…

Last month we hosted our third Health Tech Summit, bringing together our healthtech community at the London Institute for Healthcare Engineering for an afternoon filled with engaging discussions, expert insights, and canapés with a view!

QMS. Three simple letters that often instil fear and dread into healthtech developer’s minds. It needn’t be that way! A well-designed Quality Management System will not only ensure your company is compliant with the relevant legislation, it will actually enhance and improve your internal processes so that your whole team feels in control of the quality of your products.