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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Preparing for the MDSAP Audit Process: A Case Study from the Manufacturer’s Perspective

Jul 17

Real World Evidence and the NEST program: An FDA Perspective

Jul 18

eCTD Submissions — What You Need to Know to Comply with FDA Requirements

Jul 19

European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes

Jul 26

Medical Devices and the FDA Reauthorization Act of 2017: What YOU Need to Know about FDARA

Aug 1

Digital Health Tools: What YOU Need to Know — Prepare now for the FDA’s Transformative Project

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Lumithera_logo

LumiThera’s Dry AMD Treatment Device Gains CE Mark

The treatment incorporates low level light therapy, applying red and near-infrared light to improve and repair tissue.
Takeda

Consumer Group Calls for Withdrawal of Takeda’s Gout Treatment

A post-market clinical trial found higher all-cause and cardiovascular mortality in febuxostat-exposed subjects.
FDAnews Device Daily Bulletin

GI Dynamics Gets FDA OK for Clinical Trial

Aug. 27, 2012
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GI Dynamics announced approval from the FDA to skip the pilot trial usually required for medical devices, allowing the company to move directly into a pivotal clinical trial of its lead product, a device for the treatment of obese patients who have uncontrolled Type 2 diabetes.
Mass High Tech

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