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Medical Device Manufacturer

8 06, 2021

Deviation vs. Nonconformance: What’s the Difference?
Deviation vs. Nonconformance: What’s the Difference?

Deviation vs. Nonconformance: What’s the Difference?

By AssurX Blog|2021-06-08T07:00:12+00:00June 8th, 2021|Complaint Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab [...]

21 01, 2021

EU MDR Countdown: What’s Next for Medical Device Compliance
EU MDR Countdown: What’s Next for Medical Device Compliance

EU MDR Countdown: What’s Next for Medical Device Compliance

By AssurX Blog|2021-01-21T08:00:47+00:00January 21st, 2021|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]

11 01, 2021

EU MDR Compliance Check-in: Challenges and Action Items
EU MDR Compliance Check-in: Challenges and Action Items

EU MDR Compliance Check-in: Challenges and Action Items

By AssurX Blog|2021-01-11T07:36:20+00:00January 11th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The new EU Medical Device Regulation (MDR) goes into effect in less than six mon [...]

3 12, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting
How to Meet New EU MDR Requirements for Vigilance and Reporting

How to Meet New EU MDR Requirements for Vigilance and Reporting

By AssurX Blog|2020-12-03T04:26:32+00:00December 3rd, 2020|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

After a one-year delay due to concerns over a shortage of notified bodies, the n [...]

3 04, 2020

Don’t take your foot off the gas on EU MDR implementation
Don’t take your foot off the gas on EU MDR implementation

Don’t take your foot off the gas on EU MDR implementation

By AssurX Blog|2020-04-03T15:31:23+00:00April 3rd, 2020|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The coronavirus has had a massive impact on the medical device industry. As a c [...]