Archives | AssurX

The “Archives” category at AssurX serves as a repository of valuable past content, providing access to a comprehensive collection of articles, insights, and updates related to quality management and compliance. This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions. Whether you’re looking for specific information or browsing for inspiration, the archives offer a wealth of knowledge to support your quality and compliance efforts.

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 [...]

29 10, 2015

FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns

By AssurX Blog|2015-10-29T08:21:17+00:00October 29th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

A new FDA guidance calls on the medical device community to be more proactive wh [...]

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 [...]

29 09, 2015

FDA Touts Improved IDE Review Stats

By AssurX Blog|2015-09-29T08:28:21+00:00September 29th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]

22 09, 2015

Got Patient Care Ideas? FDA Wants to Hear Them

By Tamar June|2015-09-22T11:12:51+00:00September 22nd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

As promised, the FDA just announced its first Patient Engagement Advisory Commit [...]

14 09, 2015

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor

By AssurX Blog|2023-03-06T18:24:19+00:00September 14th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

The path to medical device commercialization requires FDA approval, which most o [...]

25 08, 2015

FDA Pilot Program Encourages Quarterly Malfunction Summary Filings

By AssurX Blog|2015-08-25T09:02:03+00:00August 25th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA will be taking applications starting Sept 1, 2015, looking for makers of cla [...]

19 08, 2015

FDA Takes GUDID Offline: Security breach? Or Proactive Measures?

By Tamar June|2015-08-19T07:51:11+00:00August 19th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

FDA detected a "security vulnerability" earlier this month that spooked it enoug [...]

17 08, 2015

US Drug Shortage Hits Patients, Pharmacies the Hardest

By AssurX Blog|2015-08-17T11:17:53+00:00August 17th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Patrick Stone, President, TradeStoneQA The corner drug store is not currently [...]

11 08, 2015

Cybersecurity – A Real Threat to Medical Devices

By AssurX Blog|2015-08-11T09:52:05+00:00August 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Risk Management|

The FDA just issued a Safety Communication on cybersecurity vulnerabilities of t [...]