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2020 Results: Exceptional Growth
Excellent Team and Strong Operational PerformanceΒ We ended 2020 with significant momentum, which is expected to continue in 2021 with a pipeline
Conducting clinical investigations successfully
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
CER according to the MDR
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
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
Classification of IVD under the IVDR
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
What You Need to Know About the New ISO 14155:2020 Standard
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
European Medical Device Law
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
What are the MEDDEV Guidance Documents?
MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European
What is a clinical trial?
A clinical trial is any research conducted in humans evaluating the performance and safety of an investigational product. James Lind conducted the
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