The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more
7/2/2025
/ Cybersecurity ,
Final Rules ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
New Guidance ,
Popular ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Software
Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more
8/20/2024
/ Acquisitions ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Department of Justice (DOJ) ,
Due Diligence ,
Events ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Loper Bright Enterprises v Raimondo ,
Mergers ,
Safe Harbors ,
Statutory Interpretation
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
10/5/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Biotechnology ,
Chief Compliance Officers ,
Compliance ,
Connected Items ,
Consent ,
Continuing Legal Education ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Security ,
Durable Medical Equipment ,
EU ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Medical Devices ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Physicians ,
Regulatory Requirements ,
Risk Management
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
4/24/2023
/ Acquisitions ,
Best Practices ,
Biotechnology ,
Chief Compliance Officers ,
Continuing Legal Education ,
Corporate Counsel ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Due Diligence ,
Enforcement Actions ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Mergers ,
Pharmaceutical Industry ,
Third-Party Risk