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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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Artificial Intelligence - AI in Medical Devices
As Artificial Intelligence - AI in Medical Devices continues to revolutionize industries across the globe
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GPSR 2023 988
The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect
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Harmonizating the QSR CFR 820 with ISO 13485:2016
Navigating the Transition Taken from Brian Newbery, Founder of Fast-Track QMS Consultants As we enter a new era in the regulatory...
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Regulatory Landscape for Custom-Made Medical Devices in the EU
Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes
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EU Representative - Clinical Trials
According to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, appoint a representative is required
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Examples of Class IIb medical devices
Medical device classification examples. Class IIb under MDR rules.
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Foods for special medical purposes/medical foods: A global regulatory synopsis
Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.
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MDR and IVDR Delay!
Today, 6th January 2023, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of...
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Border line products?
#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...
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FDA NEWS: Electronic Submission Template for Medical Device 510(k) Submissions
This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s.
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UPDATED GUIDANCE MHRA
This guidance document replaces the previous MHRA guidance titled “medical device standalone
software, including apps”.
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FDA allows access to over-the-counter hearing aids
FDA allows access to over-the-counter hearing aids
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