Design Dossier Web-based Seminars

Construct and Manage the Technical File and Design Dossier - Webinar GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Wednesday, May 23, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

DHF DMR DHR and the Technical File-Design Dossier - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, March 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...

The DHF DMR DHR and the Technical File Design Dossier - Regulatory Requirements - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, November 2, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of 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. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed. Why you should attend:  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...ew and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...