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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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Sep 17

Medical Device Quality & Compliance Institute 2018: Quality Systems and Design Control Training

Sep 19

Medical Device Software and Risk Management

Sep 25

De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For?

Sep 27

Emerging Biopharmaceutical Therapies: New Regulations, New Guidelines, New Incentives…

Sep 27

Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs

Oct 9

Medical Device Complaint Management: Follow the Outcomes for Regulatory Compliance

Editor's Picks

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Philips Gains CE Mark for Beltless Maternal Monitoring Device

The device features a single patch and reusable pod that are placed on the mother’s belly to capture critical parameters.
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McCaskill Demands Explanation for Nostrum’s Price Hike

“This is a shocking price increase for a generic antibiotic that was first approved by the FDA in 1953,” McCaskill said.
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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.
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Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs

Clinical Trial Risk and Performance Management Summit

De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For?