The new regulation for General Data Protection Regulation (GDPR) is effective as of May 25th, 2018. Any company that does not comply with the new regulation, can face significant fines. This change is one of the most important, if not THE MOST important in the field of privacy regulations in 20 years, and it effects […]

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New regulations in the Medtech industry (MDR) is calling for swift action to ensure timely implementation and continuous availability of medical devices. An interesting article on a call for action! Click HERE for more information. Do you need support with your existing or new medical devices? Hemex offers support at competitive conditions. Contact us today […]

The lack of private investment for start-ups and small companies in Europe encouraged the EU commission to announce that 410 MIO Euro will be made available to innovative start-ups. The process to receive those funds shall be simplified. The purpose is to retain companies to migrate to the US. HEMEX is offering partnerships and joint-ventures […]

After various incidents the control mechanisms for medical devices are being reinforced throughout Europe. Switzerland is also revising its medical devices legislation, closely modelled on the various new EU-requirements, with the aim of improving the safety and quality of medical devices. Up-to-date information (in English) can be found via THIS LINK. Let us know if […]

EMA has recently published a question-and-answer document, addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines. Here we have a document that explains key concepts in the regulation of medicines for rare diseases such as orphan designation and significant benefit. Hemex frequently submits ODD applications for Sponsors of […]

Switzerland is the leading nation for innovation for several years in a row, according to the Geneva-based World Intellectual Property Organization (WIPO). The other countries in the top five for 2017 were Sweden, the Netherlands, the United States and Britain. (WIPO global innovation index). Switzerland has held the top spot since 2011. Events like the […]