The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing
D. Stern, Matthies, Julia Hagen, Brönneke, and F. Debatin depict the point of inflexion that the Digitale-Versorgung-Gesetz (DVG) will prospectively
Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes
Under the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Device Directive (IVDD), medical device software (MDSW) was
The other side of the COVID-19 crisis highlights the strength of the biotechnology sector in our country. Since March 2020, the COVID-19 pandemic
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)
Following the publication of the MEDDEV 2.7-1 in 2016 rev 4 and subsequently Medical Device Regulation 2017/745 (MDR), medical device manufacturers
AKRN is pleased to announce the partnership agreement with the European Pharmaceutical Law Group - Eupharlaw. Health Law embraces the regulatory
Software as a medical device or in-vitro diagnostic device (part I) Over the past years, software has become an essential tool in healthcare
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