About

Mary Hutchens is in charge of Regulatory Affairs at Coalesce Product Development. She graduated as a biologist and began her career working in the agrochemical industry. Having specialised in regulatory affairs, she moved into the medical device field in 2000. She has experience in the regulation of medical devices in a variety of global markets, particularly in the EU and US.

Ms Hutchens has worked for companies ranging from large multinationals to small start-ups. She has developed regulatory strategies for new products, encompassing the creation of Design History Files and compilation of Technical Files to satisfy essential requirements. She has also commissioned clinical trials for innovative products.

Contributions

EXPERT VIEW

THE NEW EU MEDICAL DEVICE REGULATIONS – IMPLICATIONS FOR INHALATION DEVICES

Mary Hutchens gives an overview of some of the changes wrought by last year’s introduction of the new EU Medical Device Regulation, with a specific view to its effect on inhalation devices and inhaled medical products.