PubMed Literature
Medical device publications from PubMed / NCBI
[Regulatory requirements for software medical devices: Comparison between Europe, the United States, and Algeria].
Read More →The illusion of safety: A report to the FDA on AI healthcare product approvals.
Read More →Postmarket Safety Surveillance of FDA-Cleared Prescription Digital Therapeutics Using the Manufacturer and User Facility Device Experience (MAUDE) Database: A Pharmacovigilance Study.
Read More →Scoping review on regulation, implementation and postmarket surveillance of medical devices.
Read More →Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.
Read More →A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America.
Read More →Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.
Read More →Multipurpose prevention technologies for the prevention of unintended pregnancy, HIV, and other sexually transmitted infections: regulatory pathways and challenges.
Read More →Digital Therapeutics in China: Comprehensive Review.
Read More →A comprehensive overview of real-world evidence in medical device approvals in the United States.
Read More →Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024).
Read More →No matching articles.
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