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Medical device unannounced audits lessons learned

European medical device regulations are undergoing many significant changes that will impact Manufacturers, Suppliers, and Notified Bodies. The European Commission Recommendation of 24 September 2013 (2013/473/EU) introduced the immediate requirement for Notified Bodies to conduct unannounced audits on manufacturers of CE marked products. As per the Commission's recommendation, the unannounced audits will occur at least once every third year or at a higher frequency if the devices bear a high risk. The audits could occur at the legal manufacturer's premises or one of their critical sub-contractors or crucial suppliers.

BSI have now completed a substantial number of unannounced audits and this webinar will focus on the BSI experience to date with the unannounced audit program highlighting the challenges and learning points for both the Notified Body and the Manufacturers. Early experience indicates that Manufacturers with effective quality management systems with good control on sub-contractors, suppliers, and procedures/processes in place for dealing with unannounced audits fared better than others.

Please note, we will cover briefly the requirements, but the focus of this webinar is on the learning's from completed unannounced audits.