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What does your life sciences company need to market medical devices in the EU and the UK? The CE and UKCA markings and standards are your medical devices’ passport to Europe. But could their approval actually represent a technical barrier to trade? Companies willing to expand abroad have to comply with specific international trade regulations […]
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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 protestations about plastic coffee stirrers and drinking straws became insignificant, but with that phase of the pandemic seemingly behind us, the spotlight is back on environmental […]
Keep readingLearn how telemedicine and devices such as rpm monitors can make a huge difference in patient experience… and not only Remote patient monitoring leverages state-of-the-art technologies to collect real-time patient data that are helpful in improving medical decision-making, cutting healthcare costs, enhancing the relationship between doctors and the people being treated, and accelerating the digital […]
Keep readingWhen the stakes are high, every precaution is justified It is not an exaggeration to say that the accuracy of the life sciences industry is a matter of life and death. Blind back translation allows for an extra level of proofing insurance. Although CPSL’s regular translation service already includes a stringent quality assurance process, when […]
Keep readingPharmaceutical 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 […]
Keep readingMake 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, […]
Keep readingThe European In Vitro Device Regulation (IVDR) should ultimately be a great leap forward for the industry, however, most IVF device manufacturers still have a lot to do to ensure a smooth transition. Things have come a long way since British physiologist Robert Edwards and gynaecologist Patrick Steptoe gave us in vitro fertilisation – a […]
Keep readingThe technological evolution together with the recent shift towards online services have led to the development of eHealth, the healthcare practice supported by digital processes and communication. But eHealth is much more than simply using information technologies to access medical services or exchange medical information online or through an app. Learn more about the digital […]
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