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Documents Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative...

Slide 1Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Food and…

Documents The Importance of Standard Operating Procedures (SOPs) in ...

1. The Importance of Standard Operating Procedures (SOPs) in Clinical Trials 2. The Main Objective: • Be a GREAT clinical research site – For the sponsor…

Documents IRB-Investigator/ Research Coordinator Mtg. “CUMC’s New Progressive Policy For Adverse Event...

Slide 1 IRB-Investigator/ Research Coordinator Mtg. “CUMC’s New Progressive Policy For Adverse Event Reporting” April 13, 2004 George Gasparis Andrew Wit, Ph.D. Professor…

Documents Alzheimer’s Research Updates

Alzheimer’s Research Updates Alzheimer’s Research Updates 2014 ACL/CDC/NIA Alzheimer’s Webinar Series September 25, 2014 1 ACCREDITATION STATEMENTS CNE: The Centers…

Documents Clinical Trials Budgeting

+ Clinical Trials BudgetingClinical Trials Budgeting Methods & Best Practices Instructor: Jennifer L. Kellen Obj ti + Objectives Components of a clinical trial Allowable…

Documents Medicare Submission for Pre-Approval in Clinical Research Ronda Sharp, R.N., B.S.N., C.C.R.C....

Medicare Submission for Pre-Approval in Clinical Research Ronda Sharp, R.N., B.S.N., C.C.R.C. Clinical Research Facilitator Methodist Research Institute History of Pre-Approval…

Documents 510kvsPMA Slides

1 Section 3: Regulatory Pathways 2 Device Classification 3 FDA Device Classification: Risk-Based Approach • Class 1: Common, low-risk devices � General controls � Most…

Documents Investigational Devices and Humanitarian Use Devices June 2007.

Investigational Devices and Humanitarian Use Devices June 2007 Investigational device Any healthcare product that does not achieve its primary intended purpose by chemical…

Health & Medicine Recent and future developments in UDI for medical devices in the EU

1. EU UDIPERSPECTIVERAPS conference29 September 2014Erik Vollebregtwww.axonlawyers.com 2. Agenda• Policy• Recommendation• New RegulationsUDI: “The forever project”…