(571) 447-5500

Kevin Walls, MBA

EAS Independent Consultant

Kevin Walls works with a domestic and international client base on regulatory issues, compliance, submissions, and training for the Medical Device and IVD Industries. He has expert knowledge of US FDA, Health Canada and the European Medical Devices Directive regulations and his experience includes product approval/clearance submissions (e.g., 510(k)s, PMAs), combination Device/Drug submissions, Master Files for Devices (MAFs), Common Technical Document for Pharmaceutical Products, Medical Device (IDE) Clinical Trial Protocol Design, Management, Analysis and Report Writing, Quality System Manual and Quality System Procedure Origination, Design History File, CAPA, Complaint Handling, Process Control and Records Development, ISO 14971 Risk Management, FDA 483, Warning Letter and Notified Body Assessment Responses, FDA QSR and ISO 13485 Audits, Quality System Training, Auditing Medical Device and Pharmaceutical Clinical Trials, Import/Export Issues.

Posted in Who’s Who at EAS.