If the Lessons Learned sessions are a forum for exchanging experiences and thoughts, the one on 22 November was one of the clearest examples at the Parc Científic de Barcelona. It focused on sharing experiences around auditing processes for medical devices. Medical device audits can be a headache for medical device developers and manufacturers, so it is key to know exactly what the audit requirements are for international markets, who will enforce them, when and how. A medical device audit is a systematic and documented process, can be performed both announced and unannounced by notified bodies and government agencies, but must also be implemented internally as part of the company's ongoing regulatory obligations.

For this reason, experts in regulatory affairs met together to exchange knowledge and in particular, their own experiences and lessons learned in audit processes. Àngel Alonso, CEO of Vecmedical; Juan Vicente Gómez, Regulatory Affairs & QA Manager of GoodGut and Anna Cortina, QA & RA and Research Director of Avinent participated in the event which was moderated by Cristina Batlle Edo, Head of the Healthcare Area in Catalonia (Regional Government Office). 

The session was very interactive, in which the participants exchanged doubts and possible solutions related to audit planning and strategy and how to ensure that company staff are well prepared for the exams and have the necessary digital tools to respond in the most efficient way. The event ended with a networking session that allowed both the speakers and the representatives of the companies taking part to continue sharing their experiences in this area.