Recent regulatory evolutions in the EU have prompted manufacturers and notified bodies to take second looks at how medical device manufacturers control their critical subcontractors and crucial suppliers. According to the standard and regulatory texts, not much has changed in the way of requirements. In practice, however, manufacturers may need to make changes to the ways they demonstrate the monitoring of the quality system in operation, including the suppliers and contractors and show that they have integrated the quality system of the critical subcontractors and crucial suppliers with their own quality system. Join G-MED North America for a complementary webinar, Controlling Critical Subcontractors in 2014 — Regulatory Evolutions on Wednesday, February 19 at 2PM EST for a Notified Body’s perspective on controlling critical subcontractors and suppliers with the evolving requirements. The webinar will include a description of the requirements for controlling critical subcontractors and suppliers as it stands today, as well as some methods that manufacturers can use to prepare for the Recommendation’s specifics.


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