The term generative AI refers to systems which are capable of producing text, images, or other...
Medical Device Regulations Blog
The term biocompatibility refers to the interaction between materials (i.e. in medical devices) and...
Establishing an effective quality management system (QMS) is a key requirement across a number of...
Since December 2022, European regulatory bodies have been working to enact Regulation 2023/607 to...
The EUs new regulatory framework for medical devices entered into force in May 2021. As part of its...
The US Covid-19 public health emergency (PHE) is set to end on 11 May 2023. The PHE was initially...
Last month, the European Commission published an implementing decision announcing the future...
Towards the end of December last year, President Biden signed into law the Consolidated...
In January, the European Court of Justice (ECJ) published a new judgement on the medicine/medical...
The use of mobile medical apps has become increasingly prevalent in the past decade as smartphones...