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Unannounced Audits: Are You Ready?

How to Prepare and What to Ask of Your Suppliers: In an effort to thwart fraudulent medical manufacturing practices, the European Commission published a Commission Recommendation (2013/473/EU) focusing on the assessment and auditing practices of notified bodies in the field of medical devices. A particular emphasis in this Recommendation has been placed on unannounced audits. Unannounced audits are additional assessments by notified bodies of manufacturers and/or their critical material suppliers. Auditors commissioned by the notified body will be able to arrive on site without giving the manufacturer prior notice and proceed with inspection. Over 5,000 unannounced audits are expected this year alone and come in addition to the initial surveillance or renewal audits of a three-year certification cycle. Now is the time to make sure you and your supplier’s quality and supply chain management systems are in place and you have full transparency. Join us for this informational webinar discussing this trending regulatory standard and learn about what you and your suppliers should be doing to proactively prepare.

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