Description : There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market.  And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF). Areas Covered in the Session : How to meet and document their differing requirements.Required and desirable contents.Areas requiring frequent re-evaluation / update.Similarities and differences, and future convergences and trends.Typical DHF contents.Typical Technical File or Design Dossier contents.The importance and usefulness of the "Essential Requirements".Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.Parallel approaches to development.Where the Device Master Record / Device History Record "tie in".Differing approaches to records audits by the U.S. FDA and an EU Notified Body. Who Will Benefit: Middle managementR&DEngineeringSoftwareQA / RAManufacturingOperationsConsultantscGMP instructorsAll personnel especially involved in device development, regulatory compliance and documentation.