What does your life sciences company need to market medical devices in the EU and the UK? The CE and UKCA marks and standards are your medical device’s passport to Europe. But what could their approval actually represent a technical barrier to trade? Companies willing to expand abroad have to comply with specific international trade […]

It is impossible to talk about sustainable healthcare and medical device sustainability without talking about plastic waste COVID-19 made the need for billions of single-use devices essential, and our concerns about plastic coffee stirrers and drinking straws became insignificant, but now, with that phase of the pandemic seemingly behind us, the spotlight is back on […]

Pharmaceutical translators do not only deal with “simple texts”. For drugs to go to market, instructions on the production and packaging of these medications need to be carefully prepared (and translated) in order to be compliant with the FDA and EMA GMP standards. Multiple factors come into play: language work aside, collaborative and efficient DTP […]

Make the CPSL Life Sciences team part of your Master Implementation Plan for the new Medical Devices Regulation Building a roadmap for implementation of the new EU Medical Devices Regulation means defining sub-projects like translations, resource requirements, and a steering group, while ensuring overall responsibility. This major undertaking has been hindered by the COVID-19 pandemic, […]