TALG is a platinum sponsor and a spotlighted speaker this October.
IRVINE, Calif., Oct. 6, 2022 /PRNewswire/ -- TALG is attending the 2022 DeviceTalks West Conference in Santa Clara, CA. The conference takes place October 19-20, 2022, and we would be thrilled for you to join us! TALG is proud to announce that Ismail Amin, MBEE will be presenting on October 20th on FDA Device Safety & Reporting Best Practices. This session will cover the hundreds of thousands of medical device reports to the FDA concerning reports of alleged device-related injuries, deaths and malfunctions. It will examine the auspices of the FDA Medical Device Report (MDR) scheme and the mandatory reporting requirements. The session will then discuss preparation of relevant systems and protocols to provide manufacturers, distributors and importers with best practices and the Voluntary Malfunction Summary Reporting Program (VMSR) and other proactive approaches to mitigate risk.
TALG is a multi-jurisdictional law firm that solves complex problems, leveraging cutting edge technology for clients, whether in the courtroom or boardroom. Having access to capital markets is critical, and we leverage our experience in credit transactions, private equity and equity offerings to the advantage of our clients. At the production and distribution level – We understand the need for current Good Manufacturing Processes (cGMP) compliance under the relevant Codes of Federal Regulation (CFR). We have experience counseling clients with product recall issues and adverse event and problem reports (MDR) as required by the CFR(s). We've assisted our clients with 510(k) premarket notification submissions and Premarket Approvals (PMA) for Class I, II and III devices. Moreover, we have experience counseling clients with respect to Investigational Device Exemption (IDE) for clinical studies and Medical Device Reporting (MDR).
Are you interested in attending DeviceTalks West? Check out DeviceTalks West at DeviceTalks West | Premier MedTech Events to learn more about the conference. Then visit https://talglaw.com/devicetalks-west-2022/ to connect with TALG!
SOURCE Talg
