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Tag: medical device submissions

FDA Draft Guidance on Third Party Review Program: Documentation and Reporting | United States

Medical Devices
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting. Table...

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FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Computational Modeling and Engineering Analysis – RegDesk

Medical Devices
This article describes in detail the approach to be applied with respect to computational modeling and engineering analysis...

FDA on Q-Submission Program (additional overview and general considerations) – RegDesk

Medical Devices
The new article highlights the aspects related to how an applicant should submit requests for feedback and explains...

New Cybersecurity Requirements in the US

Medical Devices
Cybersecurity is a key consideration in today’s market for medical device manufacturers and other industries. I have previously written about the FDA’s expectations for...

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

Medical Devices
The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot.The joint...

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Medical Devices

AI Device Clinical Evaluation Guideline and Seven Others to be Released Soon

Medical Devices
The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022. Focusing on bio-digital integration,...

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical’s Greg Mielke

Medical Devices

Smartphone and Cheap Earbuds for Accessible Newborn Hearing Test

Medical Devices

Improved Membrane Coating for Anti-Cancer Nanoparticles

Medical Devices

Electrospun Construct Mimics Elasticity of Blood Vessels

Medical Devices

Battery-Free Light-Powered Pacemaker Now a Reality

Medical Devices

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Medical Devices
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