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Dermal fillers as medical devices under the MDR
Introduction to dermal fillers Dermal fillers are injectable soft tissue substances used in aesthetics to improve skin appearance and minimize
Introduction to dermal fillers Dermal fillers are injectable soft tissue substances used in aesthetics to improve skin appearance and minimize
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European
A clinical trial is any research conducted in humans evaluating the performance and safety of an investigational product. James Lind conducted the
Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing,
Checkout our selection of resources about medical devices and clinical writing.
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