Dhaval Shah
MEDdesign

Navigating Global Regulations for SaMD

By Dhaval Shah

…harmonizing ML best practices to better evaluate and improve ML algorithms, drive device transparency, support regulatory sciences and advance real-world performance monitoring measures. EU Regulations The EU Medical Device Regulation…

…harmonizing ML best practices to better evaluate and improve ML algorithms, drive device transparency, support regulatory sciences and advance real-world performance monitoring measures. EU Regulations The EU Medical Device Regulation…

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Karandeep Badwal

Preparing for EU MDR Post Market Reporting

By MedTech Intelligence Staff

…discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market….

…discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market….

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Regulatory Intelligence Virtual logo

MedTech Regulatory Intelligence Virtual Summit

…14 – Global Regulatory Intelligence EU MDR: Developing a Sustainable Post-market Surveillance Program What’s Happening in the UK and Switzerland Reaching the Asian Market: Certification Challenges and Considerations for China…

…14 – Global Regulatory Intelligence EU MDR: Developing a Sustainable Post-market Surveillance Program What’s Happening in the UK and Switzerland Reaching the Asian Market: Certification Challenges and Considerations for China…

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Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack

In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow…

In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow…

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Christian Götz and Dr. Jara Brenke

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz, Dr. Jara Brenke

…Surprise The EU MDR requires these products to be tested in accordance with MDR provisions. In the past, the application of these products to or in the body sometimes caused…

…Surprise The EU MDR requires these products to be tested in accordance with MDR provisions. In the past, the application of these products to or in the body sometimes caused…

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UK Flag

UK Releases Draft Post Market Surveillance Requirements for Medical Devices

By MedTech Intelligence Staff

MDR regulation and focus on Part 4A of UK MDR, post market surveillance (PMS) requirements. They include significantly more detail on the requirements for: Development of a PMS System for…

MDR regulation and focus on Part 4A of UK MDR, post market surveillance (PMS) requirements. They include significantly more detail on the requirements for: Development of a PMS System for…

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Mahdi Abbasi

MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging

By Mahdi Abbasi

…Medical Devices for Safety in the Magnetic Resonance (MR) Environment” (Docket Number FDA-2019-D-2837). European regulators also address MRI compatibility testing in the 2017 Medical Device Regulation (EU 2017/745) that defines…

…Medical Devices for Safety in the Magnetic Resonance (MR) Environment” (Docket Number FDA-2019-D-2837). European regulators also address MRI compatibility testing in the 2017 Medical Device Regulation (EU 2017/745) that defines…

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