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ZOLL Medical Corporation: ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification

ZOLL Medical Corporation: ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification
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EU continues struggle with rollout of new device regs in 2023

Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.

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Effective Clinical Evaluation Preparation Enables EU Mdr Compliance

Effective Clinical Evaluation Preparation Enables EU Mdr Compliance
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Femasys Inc. EU MDR Final Audit Successfully Completed

– Completion of the European Union Medical Device Regulation final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required...

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NICO Corporation Among Early Companies to Successfully Transition to New EU MDR Requirements for Class III Medical Devices

/PRNewswire/ -- NICO Corporation, an Indianapolis-based pioneer and leader in minimally invasive neurosurgery, announced today it is among early companies to...

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NICO Corporation Among Early Companies to Successfully Transition to New EU MDR Requirements for Class III Medical Devices

NICO Corporation Among Early Companies to Successfully Transition to New EU MDR Requirements for Class III Medical Devices
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Pharmaceutical Engineering® Announces 2021 Article of the Year

North Bethesda, Maryland (PRWEB) October 19, 2022 -- Pharmaceutical Engineering® magazine is proud to announce the 2021 Roger F. Sherwood Article of the Year

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ZimVie Reports Second Quarter 2022 Financial Results

10.08.2022 - Third party net sales of $233.4 millionNet loss of ($8.7) million; net loss margin of (3.7%); adjusted net income[1] of $17.6 million Diluted EPS of ($0.33); adjusted diluted EPS[1] of $0.67Adjusted EBITDA[1] of $31.3 million; adjusted EBITDA ...

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Clinical Challenges under the EU MDR, Upcoming Webinar Hosted by Xtalks

Toronto, ON (PRWEB) March 03, 2022 -- With the European Union (EU) Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the

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4 Ways To Prepare For UK Medical Device Regulations

Medical device companies that are working with inefficient or inaccessible systems can take these actions right now to positively affect their...

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