Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH
Alfredo J Quattrone
60 Min
Product Id: 700442
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
Best Practices in 510(k) Submissions
William G Mclain
60 Min
Product Id: 700209
This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.
Complaint Handling and Management: From Receipt to Trending
Jeff Kasoff
60 Min
Product Id: 700319
This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.
Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
John Chapman
60 Min
Product Id: 700245
This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.
FDA Compliant Marketing/Promotions for Medical Device Companies - Best Selling Package Webinar
Product Id: 701832
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.







