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FELLOW PROGRAM – THE TALENT INCUBATOR OF A CRO
In the September edition of the scientific magazine PMFarma, you can read about our Company-funded professional training program for young scientists
Roadmap to CE marking for medical devices and IVDs
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
Combination products under US FDA regulations and comparison with European regulation
The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing
“Want to See the Future of Digital Health Tools? Look to Germany”: A Review
D. Stern, Matthies, Julia Hagen, Brönneke, and F. Debatin depict the point of inflexion that the Digitale-Versorgung-Gesetz (DVG) will prospectively
MD or IVD software classification (part II)
Under the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Device Directive (IVDD), medical device software (MDSW) was
Preparation is key: Brief checklist how to bring IVD MD into compliance with EU IVDR
IVDD transition to EU IVDR The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR)
Classification of software under MDR and IVDR
Software as a medical device or in-vitro diagnostic device (part I) Over the past years, software has become an essential tool in healthcare
What is the IVDR?
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
ISO 20916 new international standard for IVDs
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
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