The 5 Major Regulatory Focus Areas For Medical Device …
Dec 10, 2024 · It looks like things will be heating up in 2025 from a regulatory perspective for the medical device industry. Several rules and regulations have important due dates in 2025 and …
Decoding The FDA's Final Guidance On PCCPs For AI-Enabled …
Dec 9, 2024 · The FDA’s final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued …
A New Approach To ISO 14971 For Better Medical Device Risk …
Oct 23, 2024 · ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well …
Understanding The New MHRA Requirements For Medical Devices …
Apr 9, 2024 · Recent developments at U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) as a result of EU MDR extensions and other factors have caused the agency …
A Closer Look At FDA's Controversial Rule On Laboratory …
Dec 3, 2024 · FDA’s recent issuance of a final rule 1 (the “rule”) on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with …
9 Strategies To Overcome Challenges In The EU Medical Device …
Dec 17, 2024 · Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical …
Key Considerations In "Intended Use" And "Indications For Use ...
Dec 14, 2023 · <p>You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, …
Medtech: Capitalize On These 4 Trends To Thrive In 2025
Nov 21, 2024 · <p>Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy medtech companies will seize for success in …
Med Device Online: Advancing human health by connecting …
Med Device Online is a resource for manufacturers involved in medical device design.
How The EU AI Act Impacts Medical Device Manufacturers
<p>The EU AI Act is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries. Here's how it …