Quality

Renovis Surgical Warned Over Quality System Violations

June 10, 2016

Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More

Health Canada Updates Essure Labels

June 10, 2016

Canada is working with Bayer to update labels and increase monitoring of its Essure birth control implant. Read More

FDA Warns German Diagnostics Maker Qiagen for TB Test Failures

June 10, 2016

The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Read More

Theranos Voids Two Years’ Worth of Blood-Test Results

June 10, 2016

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Read More

Medtronic Recalls Midas Rex Sagittal Saws

June 3, 2016

Thus far, there have been no reports of fluid leakage. Read More

FDA Yanks MQSA Certificate From California Radiology Facility

June 3, 2016

In a rare move, the FDA has revoked the mammography quality standards act certificate from a California radiology facility. Read More

Cordis Recalls Precise Pro RX System

May 31, 2016

The device is intended for use in patients with stenotic lesions of the carotid artery. Read More

Medtronic Recall Reaches Class 1 Status

May 27, 2016

The recall over fire risks involves 9,817 battery packs. Read More

CDRH Adds Five Online Resources for UDI Program

May 20, 2016

The FDA has added five new modules to its CDRH Learn online platform covering the Unique Device Identification program. Read More

A Quality Management Journey: How to Avoid Repeat CAPAs

May 20, 2016

Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Read More

Firm Hit With 10 Observations Over Alleged Reporting Issues

May 9, 2016

The FDA is accusing a medical devicemaker of neglecting to report five cases of radiation leakage from its products and other reporting violations, according to a 10-observation Form 483. Read More

FDA Extends Comment Period for Refurbishing Medical Devices

May 9, 2016

The FDA is extending a comment period to June 3 for its proposal to redefine third-party servicing for medical devices. Read More

Quality
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Renovis Surgical Warned Over Quality System Violations

Health Canada Updates Essure Labels

FDA Warns German Diagnostics Maker Qiagen for TB Test Failures

Theranos Voids Two Years’ Worth of Blood-Test Results

Medtronic Recalls Midas Rex Sagittal Saws

FDA Yanks MQSA Certificate From California Radiology Facility

Cordis Recalls Precise Pro RX System

Medtronic Recall Reaches Class 1 Status

CDRH Adds Five Online Resources for UDI Program

A Quality Management Journey: How to Avoid Repeat CAPAs

Firm Hit With 10 Observations Over Alleged Reporting Issues

FDA Extends Comment Period for Refurbishing Medical Devices

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