Shuna Mason is a partner in the Lifesciences group at CMS UK and is the firm’s lead on regulatory and product liability issues.
She specialises in the lifesciences and consumer products sectors, covering pharmaceuticals, medical devices, in vitro diagnostic devices, human tissue, cosmetic and plant protection products.
Shuna advises companies on regulatory, compliance and liability issues in relation to product lifecycles as well as business models, on both international as well as national issues. She frequently manages and co-ordinates international regulatory, compliance and liability / litigation advice. She is also actively involved in UK and European trade associations in the medical devices and diagnostics sectors, including as an invited member of the MedTech Europe legal affairs focus group and its ethical business code committee and brings a broad perspective on healthcare sector issues when advising clients.
Shuna’s team advises in relation to pre-market development, market authorisation or conformity assessment as well as in relation to (pharmaco-)vigilance and other post-market compliance issue, including postmarket surveillance, field safety corrective action, labelling/IFU and all types of promotional materials and activities, including compliance.
Shuna has extensive experience in handling English product liability disputes and other litigation, including regulatory enforcement and judicial review administrative challenges. She is also familiar with co-ordinating and managing product liability litigation and recalls across Europe and beyond for manufacturers and insurers.