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Tag: Devices

SFDA Guidance on AI- and ML-based Medical Devices: Overview

AI
The document provides an overview of the regulatory approach to be applied with respect to medical devices based...

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Analysis and Changes to Pivotal Studies

Medical Devices
The new article addresses the aspects related to the way study results should be analyzed, and also the...

FDA Draft Guidance on Denying or Limiting an Inspection

Medical Devices
The new article highlights the aspects related to behaviors considered denying or limiting an inspection. ...

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Conduct

Medical Devices
The new article highlights the key points to be considered when conducting a study in order to sustain...

MDA Draft Guidance on Applications of CFS, MC and CFS EO Certificates: Overview

Medical Devices
The article provides an overview of the draft guidance document describing the procedures related to certain certificates related...

FDA Draft Guidance on Delaying an Inspection: Reasonable and Unreasonable Delays

Medical Devices
The new article addresses the aspects related to different grounds for delays occurring before and during an inspection....

New opportunity: Filmmakers, You Need to Know About The Power Junkie v2 – 2023-01-27

Crowdfunding
Funding data (27 January 2023) Raised GBP 11,784.00 Min. Goal GBP 4,000.00...

Advanced Wound Care Market Report 2023: Growing Prevalence of Diseases & Conditions Affecting Wound Healing Capabilities Boosts Sector – ResearchAndMarkets.com

Fintech
DUBLIN–(BUSINESS WIRE)–The “Advanced Wound Care Market by Product (Dressings (Foam, Hydrocolloid, Film, Alginate), NPWT, Debridement Devices, Grafts, Matrices, Topical Agents), Wound Type (Surgical, Traumatic,...

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Sotera Health Company (SHC) on Behalf of Investors

Fintech
LOS ANGELES–(BUSINESS WIRE)–Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on...

CloudSort Corporation Makes Its Official Mark at MANIFEST 2023

Fintech
With a New Vision for the Middle Mile, Cloudsort’s Revolutionary Cloud-Based Sortation Software Platform is Transforming Legacy Logistics that have kept the Supply Chain...

NEW PRODUCT – Adafruit ESP32-S2 Reverse TFT Feather

IOT
NEW PRODUCT – Adafruit ESP32-S2 Reverse TFT FeatherLike Missy Elliot, we like to “put our down, flip it and reverse it” and that’s exactly what...

PayNearMe’s Jill Bohlken on the Unpredictable Lending Environment

Fintech
Lenders have always faced some level of uncertainty, but the past few years have truly put the industry to the test. While...
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