Quality Management Solutions by AssurX

Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.

31 10, 2016

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

By AssurX Blog|2023-03-08T22:42:36+00:00October 31st, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.

24 10, 2016

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

By AssurX Blog|2023-02-27T20:08:48+00:00October 24th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.

27 09, 2016

Cloud for quality and compliance management: A primer for life sciences companies
Cloud for quality and compliance management: A primer for life sciences companies

Cloud for quality and compliance management: A primer for life sciences companies

By AssurX Blog|2024-03-26T20:18:20+00:00September 27th, 2016|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.

19 09, 2016

RAPS Preview: FDA CDRH Director Shuren Talks Priorities
RAPS Preview: FDA CDRH Director Shuren Talks Priorities

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

By AssurX Blog|2023-02-28T15:35:39+00:00September 19th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD [...]

5 11, 2015

FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline

By AssurX Blog|2015-11-05T11:39:30+00:00November 5th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Medical device warning letters and domestic inspections continue to show a slow [...]

3 11, 2015

Improving FDA Reviews of Combination Products
Improving FDA Reviews of Combination Products

Improving FDA Reviews of Combination Products

By AssurX Blog|2023-03-06T18:23:10+00:00November 3rd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf [...]

14 10, 2015

FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide

By AssurX Blog|2015-10-14T20:01:35+00:00October 14th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Our latest round of warning letters emphasize the importance for medical device [...]