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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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Aug 14

MDR Adverse Event Codes for Devicemakers

Aug 15

Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers

Aug 16

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead

Aug 22

Corporate Compliance & Liability: What Medical Product Professionals Need to Know

Aug 23

Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

Aug 23

What CDER Can and Can’t Do: An Inside Look from an Agency Official

Editor's Picks

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7D Surgical’s Cranial Module Device Receives FDA Approval

The device can register multiple datasets to visualize the patient’s anatomy using many types of medical imaging.
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NICE Reverses Decision to Reject Besponsa

The institute said that the medicine could be an important treatment option for individuals with ALL and is generally well tolerated.
FDAnews Device Daily Bulletin

DELPHI MEDICAL SYSTEMS EXPANDS IN THE RESPIRATORY CARE MARKET WITH WEARAIR LICENSING AGREEMENT

Dec. 13, 2005
KEYWORDS FDAnews Device Daily Bulletin
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Delphi Medical Systems, a subsidiary of Delphi Corp., recently signed an exclusive worldwide licensing agreement with Canada-based medical device company WearAir Oxygen, Inc. WearAir is a small company with a mission to improve respiratory patients' quality of life through an innovative proprietary oxygen concentration technology.

Yahoo News (http://biz.yahoo.com/prnews/051212/dem008.html?.v=28)

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