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Medical Devices › Risk Management › Patient Safety

Hinshaw & Culbertson - Health Care

Beyond the Glow: Key Medical Spa Compliance Challenges and Legal Pitfalls

Hinshaw & Culbertson - Health Care on

The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more

Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Gardner Law on

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

Robinson+Cole Data Privacy + Security Insider on

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Hogan Lovells

Parsing products: FDA regulatory policy for multi-function medical devices

Hogan Lovells on

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

Hogan Lovells

FDA signals increasing focus on cybersecurity requirements

Hogan Lovells on

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

Hogan Lovells on

Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

Hogan Lovells

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

McDermott Will & Emery

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

McDermott Will & Emery on

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

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