Clearance Web-based Seminars

Device Changes and the 510k - Webinar GlobalCompliancePanel Overview: The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. Wednesday, May 9, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

510k Submissions Requirements Challenges and Successful Clearance - Webinar By GlobalCompliancePanel Overview: A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. Thursday, April 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Specializing in Treating the Phobic Patient - Webinar By mentorhealth Treating the phobic patient is analogous to the clinician acquiring a new skill like implantology. It requires knowledge of the three primary medications used; the indications and contraindications. The only financial investment will be a pulse-oxymeter (to monitor vital signs during treatment). Tuesday, October 18, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ... public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you should attend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ale. Areas Covered in the Session: * FDA Device Clearance / Changes in Direction * Product Changes and Filing a New 510(k) Responsibilities * Tracking / Evaluating Changes and the "Tipping Point" * "Risk-Based" * FDA's K97-1 and "Decision Tree" Model / Matrix * Resolving a "Wrong" Decision Who Will Benefit: * Senior management in Devices and Combo  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of  more...