Description : This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"Areas Covered in the Session :. This session will cover:Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1How to provide tools to document such decisionsIt will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warrantedHow to structure a decision matrix to document change decisionsHow to evaluate changes that could trigger the "Tipping Point"Who makes the decisions and how to defend themHow to implement formal methods with documented, and defensible rationalePreparing for further 510(k) changes in the futureWho Will Benefit:This webinar is a must for companies in the Medical Device and combination products fields. The employees who will benefit include:Research & DevelopmentEngineering StaffQuality AssuranceRegulatory AffairsLean & Six Sigma staffNew Product DevelopmentMarketingMid-level and Senior ManagementProject LeadersConsultantsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458