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Highlights

August 05, 2022

FDA EMC of Medical Devices: Nearfield Emitters New Immunity Testing

On June 6^th 2022 FDA issued an update to the guidance on EMC of Medical Devices. This blog helps illuminate some of the new information in this latest guidance from the FDA on EMC, specifically RFID.

FDA Medical Devices Highlights

Qserve supports you in supporting the Ukraine

Our feelings, prayers and our support are for all Ukrainians who are fighting for their right to exist.

Medical Devices Ukraine Highlights

Results

October 05, 2022

Stéphane Naudin joins Qserve Group

Biocompatibility Medical Device Regulations Medical Devices Notified Body Risk Management Technical Documentation

October 04, 2022

The secret of SaMD?

We visit our special Medical Device Company again. This time they want to expand their portfolio and launch a SaMD-App. How will this work as there are rumors that software as a medical device is supposed to be complicated, hard to understand, and the regulatory requirements are all in the dark?”

Quality Assurance

September 30, 2022

Two new directive proposals were published by the European Commission on the liability of manufacturers

On September 28th, the European Commission published two directive proposals for the liability of manufacturers.

AI Medical Devices Highlights

September 27, 2022

Free Webinar PPT Download | A year+ after MDR implementation - All we have learned

Medical Devices On-Demand Webinar

September 27, 2022

On-Demand Webinar | A year+ after MDR implementation - All we have learned

Medical Device Regulations On-Demand Webinar Highlights

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