The concept of equivalence in the European’ MedTech sector In Europe, medical device manufacturers with products on the market have long used
Excellent Team and Strong Operational Performance We ended 2020 with significant momentum, which is expected to continue in 2021 with a
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
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
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