EU MDR | AssurX

The “EU MDR” category at AssurX focuses on aiding organizations in meeting the European Union’s Medical Device Regulation (MDR) requirements. This section delivers insights into quality management, compliance strategies, and process optimization, specifically for medical device manufacturers. Key topics include understanding MDR mandates, ensuring product safety, and maintaining high standards of quality and performance. With AssurX’s expertise, professionals can navigate the regulatory landscape, improve operational efficiency, and drive innovation to meet all necessary EU MDR standards.

25 04, 2023

Update: EU Medical Device Regulation Deadlines Extended
Update: EU Medical Device Regulation Deadlines Extended

Update: EU Medical Device Regulation Deadlines Extended

By Stephanie Ojeda|2024-03-04T21:19:23+00:00April 25th, 2023|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]

29 11, 2022

How Hybrid Audits Can Help MDR Compliance in the European Union
How Hybrid Audits Can Help MDR Compliance in the European Union

How Hybrid Audits Can Help MDR Compliance in the European Union

By Stephanie Ojeda|2022-11-29T08:48:10+00:00November 29th, 2022|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments
Why an EQMS is Essential for FDA Remote Regulatory Assessments

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By Stephanie Ojeda|2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]

25 08, 2022

EU MDR & IVDR Regulation: Where Does the Guidance Stand?
EU MDR & IVDR Regulation: Where Does the Guidance Stand?

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

By Stephanie Ojeda|2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies marketing devices in the European Union are facing a perfect storm of [...]

30 06, 2022

EUDAMED Update: What You Need to Know Now
EUDAMED Update: What You Need to Know Now

EUDAMED Update: What You Need to Know Now

By Sal Lucido|2022-06-30T21:11:53+00:00June 30th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation Still Presents Challenges and Opportunities

EU Medical Device Regulation Still Presents Challenges and Opportunities

By Sal Lucido|2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

15 02, 2021

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

By AssurX Blog|2021-02-15T09:20:39+00:00February 15th, 2021|AssurX News + Success Stories, EU MDR, Medical Device Industry, Uncategorized|

Join us for a one-hour webinar focused on efficient management of postmarket cha [...]

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 [...]

19 01, 2021

Addressing the EU MDR and IVDR Certification Bottleneck
Addressing the EU MDR and IVDR Certification Bottleneck

Addressing the EU MDR and IVDR Certification Bottleneck

By AssurX Blog|2021-01-19T07:00:36+00:00January 19th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]

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 [...]