Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

Digital Health in Germany

Germany’s digital health sector is booming, but navigating market access, regulatory compliance, and reimbursement pathways is challenging.

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The UK medical device regulatory framework is based on UK MDR 2002, with oversight by the MHRA.

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As Artificial Intelligence - AI in Medical Devices continues to revolutionize industries across the globe

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The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect

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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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Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes

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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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Medical device classification examples. Class IIb under MDR rules.

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Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.

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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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#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...

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This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s.

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This guidance document replaces the previous MHRA guidance titled “medical device standalone software, including apps”.

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