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Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations - QbD Group

Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

Clinical Medical Devices

Nov 17, 2023 6:45:00 PM

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is ...

CE approval for Medical Devices under MDR: key requirements for your device class - QbD Group

CE approval for Medical Devices under MDR: key requirements for your device class

Clinical Medical Devices

Oct 31, 2023 11:15:00 PM

Conformity assessments for CE approval As indicated on the website of the European Commission, a med...

State Of The Art Literature Review – Process and Documentation - QbD Group

State Of The Art Literature Review – Process and Documentation

Clinical Medical Devices

Jul 3, 2023 12:30:00 AM

A comprehensive, objective, and thorough systematic literature review to describe the general State ...

MDR transition: how to plan MDR compliance for your Medical Device? - QbD Group

MDR transition: how to plan MDR compliance for your Medical Device?

Clinical Medical Devices

Apr 26, 2023 7:00:00 AM

In June 2022, concerns were expressed that severe challenges related to the implementation of Regula...

Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare - QbD Group

Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Clinical Medical Devices

Apr 20, 2023 7:45:00 AM

Nowadays, regulations on medical devices and medicinal products have very strict expectations on doc...