How to Prepare and Submit a Bullet Proof 510(k) Submission
David Dills
60 Min
Product Id: 700981
This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.
Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities
Robert A North
60 Min
Product Id: 700912
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.
Beyond Usable to Valuable: Usability Testing on Medical Device Labeling
Patricia A Patterson
60 Min
Product Id: 700879
Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI). Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.
Risk Communication of Medical Device Failures
Marta L Villarraga
60 Min
Product Id: 700450
This Risk communication webinar/training will review the types of risk communications that take place regarding medical device failures at both pre- and post-marketing stages in the lifecycle of medical devices.
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.







