WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,

FL,

US,

ZIP: 33021

Phone: 347 282-5400

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Initially, FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule). The Proposed Rule contains four types of proposed changes to FDA’s device establishment registration and device listing regulations. For example, Proposed Rule would amend FDA’s current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. 
 

Areas Covered

 

•      When and how to register and list
•      Review the four major changes to FDA’s device establishment registration and device listing regulations
•      Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices
•      Other proposed Amendments that would change current device establishment registration and listing requirements
•      Replacement of the current regulations regarding updating device listing information outside the required update periods
•      Clarification of who must provide establishments’ registration numbers

 

Who will Benefit

 

This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the establishment registration and listing process from start to finish, including:

•     Regulatory Affairs
•     Quality and Compliance
•     Marketing & Sales 
•     Importers
•     Distributors/Authorized Representatives
•     Legal Counsel
•     Engineering/Technical Services/Operations
•     Consultants

Speaker Profile

David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.