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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.

Events

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Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Editor's Picks

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MHRA Recalls Digital Pregnancy Tests

The recall affected one lot involving 58,000 tests distributed in the UK. 
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Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force.
FDAnews Device Daily Bulletin

TOPSPIN MEDICAL GETS FDA APPROVAL TO START CLINICAL TRIALS IN THE US AND COMPLETES THE DEVELOPMENT OF A PROTOTYPE OF ITS ADVANCED GENERATION INTRAVASCULAR MRI (IVMRI) CATHETER

July 10, 2006
KEYWORDS FDAnews Device Daily Bulletin
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TopSpin Medical announced it has received FDA approval to start conducting clinical trials in the US with its IntraVascular MRI (IVMRI) catheter, intended for the characterization of lipid-rich lesions in the coronary arteries. TopSpin IVMRI catheter technology enables MRI to be performed in the clinic for the first time with no external magnets. To date the company conducted clinical trials with its IVMRI catheter in more than 70 patients in Europe and Israel, and following the FDA approval TopSpin intends to extend the clinical trials to leading US clinical sites.

Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=3171975)