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Risk Management Software Manufacturers

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

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

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

Goodwin on

The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

Warner Norcross + Judd on

The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Foley & Lardner LLP

Technology Trends in Manufacturing and Associated Legal Risk Management: Driving Technological Advancement with an Ecosystem View 

Foley & Lardner LLP on

The importance of building technology-driven manufacturing businesses with an ecosystem focus—i.e., a comprehensive view of the complex network of suppliers, partners, and customers in a market—emerged as a critical theme for...more

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