This issue we are focusing on the MDD Amendment 2007/47/EC including our toolkit to make your transition much easier and an interpretative EC guidance on the implementation of 2007/47/EC.  These are both great resources to use to get you thru this transition.  Also, we will focus on EU vigilance reporting per MEDDEV 2.12-1, revision 5 and record retention requirements per ISO 13485, ISO 9000, MDD, AIMDD, & IVD.  These last two topics are good reminders to check your quality system procedures, forms, and records to ensure you are meeting the proper requirements prior to your next audit by a registrar or EU Notified Body.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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