Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.
Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.
A UK Government report finds that unsafe and non-compliant products can cost businesses up to £400 per item, with hidden impacts like recalls, lost sales, and reputational damage, making compliance a key business priority.
The MHRA has launched a 2026 consultation on the future of CE marking in Great Britain, proposing its indefinite recognition for medical devices. The outcome could significantly impact regulatory requirements.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced new steps to reinforce its collaboration with the US Food and Drug Administration (FDA).
