As most medical companies know the 2022 deadline approaches for the transition from the EU IVD Directive (IVDD) to IVD Regulation (IVDR) as well as new MDR regulations. They have significant differences to the old directives.Increasingly language translation has become a core activity to obtain regulatory compliance in all sectors. A successful regulatory strategy for […]

  With this COVID-19 pandemic we are seeing amazing acts of kindness and co-operation at all levels. The medical device industry has been very agile in responding to the pandemic, Pat Shafer MD of Grant Thornton Healthcare says. “Most manufacturing has not had any production stoppages, and factories are still open, and many have sufficient […]

1. The Norway model Member of European Economic Area, full access to single market, obliged to make a financial contribution and accept majority of EU laws, free movement applies as it does in the EU. 2. The Switzerland model Member of the European Free Trade Association but not the EEA, access to EU market governed […]

Over the last few years, social media and social networking have completely change the way people use the internet. Twitter, Facebook, Youtube and corporate blogs have become an integral part of companies’ marketing mix. In fact, even if the commercial benefits of social media are difficult to quantify, social media have a crucial role in […]