As we start the New Year, Dr Manuela Gazzard, Group Director of Regulatory Services at BSI, celebrates the achievements of the Medical Devices team in 2020, despite being a challenging year for us all. Manuela also provides an update on BSI’s leadership, the expansion of the Medical Devices team to support clients with IVDR, MDR and QMS applications, and the full-scope designation of BSI UK to the new UKCA scheme, as we remain committed to our mission of ensuring patient safety while supporting timely market access to medical device innovation.