Morrison Foerster is an international law firm with lawyers practicing throughout the United States, Asia, and Europe. Click to discover more.

mofo_share_image.jpg

Morrison Foerster

common-default.jpeg

Terms / Notices

Cookies

Privacy Policy

Reporting Hotline

Attorney Advertising

Alumni

  Linkedin

MoFo LinkedIN

  Facebook

MoFo Facebook

YouTube

MoFo Youtube

Morrison Foerster - Footer

MedTech Meets AI: Navigating Legal Insights on AI Integration

You have not solved the recaptcha challenge yet or session expired, try again.

Email Disclaimer

Disclaimer

Unsolicited e-mails and information sent to Morrison Foerster will not be considered confidential, may be disclosed to others pursuant to our <a href="https://www.mofo.com/about/privacy-policy.html">Privacy Policy</a>, may not receive a response, and do not create an attorney-client relationship with Morrison Foerster. If you are not already a client of Morrison Foerster, do not include any confidential information in this message. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.

Feedback

mofo-logo-2022.svg

People

Capabilities

Resources

About

Community

Offices

Careers

Stay Connected

Erin Bosman, global co-chair of Morrison Foerster’s Litigation Department, and Brigid Bondoc, partner in the firm’s FDA and...

<h3>Sorry, we weren’t able to find the terms you entered.</h3>Please try a different term or keyword.

People

Capabilities

Resources

Not Found Cards

Erin Bosman, global co-chair of Morrison Foerster’s Litigation Department, and Brigid Bondoc, partner in the firm’s FDA and Healthcare Regulatory and Compliance practice, will speak in the webinar MedTech Meets AI: Legal Insights on AI Integration, cohosted by AdvaMed and Morrison Foerster. The program will explore the evolving legal landscape surrounding artificial intelligence in medical devices, with a focus on product liability risks and the shifting regulatory treatment of software as a product.<hr>

MedTech Meets AI: Navigating Legal Insights on AI Integration

Sign Up

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.Erin's clients value her litigation acumen, retaining her as national coordinating and trial counsel in class action cases and multijurisdictional and multidistrict proceedings. She navigates complex business relationships and serves as a defense liaison counsel in cases where multiple defendants have conflicting defenses. A skilled negotiator, Erin has a long track record of securing dismissals and favorable settlements for her clients. When trial is needed, her compelling courtroom skills have delivered successful jury verdicts and appellate victories.Outside the courtroom, Erin maintains a robust advisement practice, drawing on her litigation experience to counsel clients on product development, risk assessments, product labeling, and risk mitigation strategies to help them avoid and defeat product liability claims. When necessary, Erin advises on crisis management and guides clients through product recalls, representing clients before the Consumer Product Safety Commission (CPSC).Erin is a problem-solver through and through. In that role, she advises clients on some of their most difficult product questions, with particular focus on emerging technologies in untested regulatory and litigation landscapes. She is a leader in the fields of wearables and digital health, medical device and pharmaceuticals, and consumer products. Erin counsels clients that have innovative products in the technology and artificial intelligence sector. In addition to her knowledge and experience in the AI space, Erin has also advised clients working with autonomous vehicles, sensors, robotics, and IoT.Erin has received numerous accolades for her legal work, including by the Daily Journal, Chambers USA, and The Legal 500 US, where market commentators praised her as “an exceptional strategist with highly effective negotiation skills” who “has the respect and admiration of her team and her clients.” Erin is a two-time recipient of  “Product Liability Lawyer of the Year” from Euromoney America’s Women in Business Law Awards, honoring high-achieving female lawyers and progressive law firms. In 2025, Erin was again recommended in Mass Tort Litigation/Class Actions – Defendants by Best Lawyers in America. The Legal 500 continues to recognize Erin as a Leading Lawyer in Dispute Resolution: Product Liability, Mass Tort, and Class Action. She was also named as a “Top Healthcare Lawyer” by the Daily Journal, honoring her as a leading California lawyer who specializes in healthcare litigation, transactions, and counseling. Erin was also short listed in the Financial Times’ North American Innovative Lawyers Awards in the Most Innovative Legal Practitioner category for her expertise in solving clients’ problems.Erin is a member of the Product Liability Advisory Council (PLAC), a member of the editorial board for Product Liability Law 360, and a former editor of and frequent contributor to MoFo’s <a target="_blank" href="http://classdismissed.mofo.com/">Class Dismissed</a> blog.<h5>More About Erin</h5>In 1997, Erin was a judicial extern for the Honorable James F. Stiven, U.S. Magistrate Judge, Southern District of California. In 1999, she received her J.D. magna cum laude and Order of the Coif from the University of San Diego School of Law. During law school, she was an editor of the San Diego Law Review.

Erin Bosman

Co-Chair, Litigation Department

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

MedTech Meets AI: Navigating Legal Insights on AI Integration

23 Sep 2025 1:00 PM - 2:00 PM EDT