The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing over the last decade.
Read moreUnder the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Device Directive (IVDD), medical device software (MDSW) was generally considered to be low risk and, therefore, a low-class...
Read moreThe upcoming application of the Medical Device Regulation (#MDR) on May 26th 2021 may signify your digital solution is subject of qualification as a Medical Device. Software as Medical Device (SaMD) m...
Read moreMowoot, a start-up and CataloniaBio & HealthTech member, has published its first international clinical trial showing the efficacy and safety of the medical device in treating chronic constipati...
Read morePublicada la revisión de la guia MDCG 2020-4 «Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions» ...
Read moreBy adopting the Digital Healthcare Act (DVG) (October 5th, 2019), Germany became a pioneer in Healthcare App insured prescription, marking one of the greatest milestones for the Medical Device Softwar...
Read moreMJN Neuroserveis, a CataloniaBio & HealthTech member, has obtained the CE mark certification for a non-invasive medical device to help people with epilepsy improve their quality of life, together w...
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