June 27, 2019
The 510(k) process has been the subject of recent media attention as well as litigation. Many have alleged that “substantial equivalence” is too low a bar for clearance of medical devices and have called for more rigorous investigation on the part of the FDA. In this webinar, seasoned attorneys Beth...
Previously Recorded on April 24, 2019
The success (or failure) of a company is determined in large part by its products and how its technology differentiates those products from competitors’. This is especially true in the life sciences industry, where newcomers to the market and veterans alike need to be aware of potential pitfalls in...
Previously Recorded on March 20, 2019
With the U.S. House and Senate divided along political lines, and the longest government shutdown behind them, Congress has begun to lay out its healthcare agenda for the 116th Congress. With a presidential election forthcoming, Congress and the executive branch—specifically, the Department of Healt...
Previously Recorded on February 27, 2019
The evolution of MRI safety compatibility testing, coupled with the European MDR requirements to evaluate devices for safety with respect to external electric and magnetic fields, has necessitated the evaluation and in some instances re-evaluation of medical devices for MRI safety. Testing for MRI s...
Previously Recorded on January 16, 2019
In this annual webinar, two attorneys in Medmarc’s Risk Management Department will break down some of the biggest headlines from the last year and discuss what life sciences companies can take away from these stories and what they should have their eyes on in 2019. Specifically, this webinar will di...
Previously Recorded on December 11, 2018
In this year's annual year-end wrap up, Sonia Valdes, Medmarc's Vice President of Claims, and respected products liability defense attorney, Adam Porter with Butler Snow, will summarize the State of the Medical Device Industry, from the court of public opinion to the United States Supreme Court. We...
Previously Recorded on November 16, 2018
Ethical conduct is critical in all business operations, but especially so in industries like life sciences, where health and safety are at stake. Codes of ethics can serve as a statement to outside stakeholders and policymakers about the types of behavior and business practices that an industry view...
Previously Recorded on September 19, 2018
For life science startups, two of the primary sources of non-dilutive funding are Grants and the Payroll/Startup Research & Development (R&D) Tax Credit, which allows startups to offset payroll taxes before they become profitable. Both programs are intended to spur innovation and accelerate growth i...
Previously Recorded on August 30, 2018
Even the safest products may be the subject of products liability lawsuits at some point, and companies involved in bringing those products to market need to be ready before problems arise. This webinar provides a survival guide for life sciences companies facing new litigation. Seasoned products li...
Previously Recorded on July 18, 2018
In this webinar, seasoned regulatory attorney Edward C. Wilson, Jr., Partner at Hogan Lovells’ Washington, DC, office, details what an effective complaint-handling system looks like for a medical device company, explains how to measure the effectiveness of such a system, and provides improvements fo...
Previously Recorded on June 27, 2018
The design is complete. The label is finalized. The product is approved and sold. But the risks of liability don’t end there. In this webinar, Butler Snow LLP’s Kyle Cummins will discuss relevant post-sale duties and products liability doctrines affecting manufacturers after a product is on the mark...
Previously Recorded on May 29, 2018
Two new major pieces of legislation – the Food and Drug Administration Reauthorization Act (FDARA) and the 21st Century Cures Act – will likely have serious effects on your business, and failure to comply with them may even make your operations vulnerable to shut down. This webinar will look at how...
Previously Recorded on April 25, 2018
The Department of Justice places a high priority on criminally prosecuting individuals including sales reps and executives for their corporations’ misconduct, including misconduct often at the heart of products liability lawsuits. In this webinar, Andrew Tharp of Butler Snow LLP will discuss DOJ cri...
Previously Recorded on March 21, 2018
Learn how you can leverage one of the top trends in the medical device industry, the MedAccred program. Many of the leading medical device companies, such as Johnson & Johnson, Philips, Stryker, Medtronic, Baxter, and Boston Scientific, are using MedAccred to improve product quality and most importa...
Previously Recorded on February 27, 2018
In an increasingly litigation-driven world, even the best of intentions (and FDA approval) in labeling considerations do not act as a shield to liability. In this webinar, Kasey Adams from Butler Snow LLP will focus on some of the most prevalent issues in “failure-to-warn” and “defective warning” cl...
Previously Recorded on January 24, 2018
This one-hour webinar will review and bring you up to date on: Recent FDA enforcement trends for device and pharma firms – what can we expect? Data integrity enforcement – how FDA is expanding this beyond pharma to CDRH and CVM Where FDA is on their rollout of the new inspection methodologies NIPP...
Previously Recorded on December 13, 2017
In this year's annual year-end wrap up, Sonia Valdes, Medmarc's Vice President of Claims, and respected products liability defense attorneys, Lisa Rice and Laurie Sherwood of the Walsworth firm, will summarize the significant life sciences cases, verdicts, and settlements of 2017. They will also de...
Previously Recorded on October 23, 2017
In a time of rapid scientific and technological development, and with the tidal wave of change brought by a new administration, life sciences topics are frequently in the news. In this webinar, the attorneys in Medmarc’s risk management department will take you through a few of the year’s most cogen...
Previously Recorded on September 20, 2017
In an increasingly electronic world, the types and scope of electronically stored information (“ESI”) continue to expand. Preserving ESI and understanding your company’s ESI obligations are critical in the claim and litigation process. The key piece of evidence that you need to defend your product i...
Previously Recorded on September 13, 2017
As part of our continued collaboration with the Performance Research Institute (PRI), developer of the MedAccred program for medical-device supply-chain accreditation, Medmarc is hosting the last webinar in this six-part webinar series on critical manufacturing processes. This webinar focuses on Wel...
Previously Recorded on August 23, 2017
This year has seen many changes in Washington and a corresponding myriad of change for the medical device industry. In this webinar, VP of Government Affairs for MDMA (Medical Device Manufacturers’ Association), Clayton Hall, will take us through what’s going on in D.C. and the politics and policies...