Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

21 11, 2014

Are You Ready for 21st Century eMDR Submissions?
Are You Ready for 21st Century eMDR Submissions?

Are You Ready for 21st Century eMDR Submissions?

By AssurX Blog|2014-11-21T10:35:19+00:00November 21st, 2014|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]

5 11, 2014

Report: Medical Device Approval Still Lags, but FDA is Trying

By AssurX Blog|2024-12-31T23:59:45+00:00November 5th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

After years of decline, the speed of FDA device approvals has finally begun to h [...]

31 10, 2014

FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts

By AssurX Blog|2023-03-14T22:46:53+00:00October 31st, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

The Food and Drug Administration (FDA) reported that there have been over 240 us [...]

30 10, 2014

FDA Works to Soothe Industry at Medical Device Cybersecurity Webinar

By AssurX Blog|2014-10-30T08:55:21+00:00October 30th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

The FDA will focus more on a device maker's overall approach to ensuring cyberse [...]

1 10, 2014

Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright

By AssurX Blog|2014-10-01T08:08:26+00:00October 1st, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

Well, Halloween is approaching boys and girls. And while it's fun to don a Dracu [...]

17 09, 2014

The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See

By Tamar June|2014-09-17T13:49:20+00:00September 17th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

In a previous post we looked at the FDA's relatively ho-hum guidance on social m [...]

15 09, 2014

It’s Time to ‘Get’ IEC Before It ‘Gets’ You

By AssurX Blog|2023-03-06T18:30:42+00:00September 15th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

FDA medical device recalls are on the rise. An increasingly active FDA, coupled [...]

26 08, 2014

FDA IDE Guidance Offers Industry Important Clarity

By AssurX Blog|2023-03-06T21:04:29+00:00August 26th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Inve [...]

13 08, 2014

FDA Guidance Advises Device Makers to Think About Home-Use

By AssurX Blog|2023-03-08T22:51:31+00:00August 13th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Medical device manufacturers would be well-advised to address any potential home [...]

5 08, 2014

FDA Spreads Regulatory Love Nationwide

By AssurX Blog|2023-03-08T22:52:50+00:00August 5th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Detroit may be struggling with bankruptcy, but in a flurry of activity that woul [...]