EUDAMED: Registration Roles for Importers and Distributors
Who registers what in EUDAMED: the manufacturer, authorised representative, importer and distributor roles, and the data each has to keep current under...
Read ArticleCE, ISO 13485, FDA, MDR, IEC 60601, RoHS, REACH, UDI, Free Sale, Apostille, and vigilance reporting for medical equipment.
Who registers what in EUDAMED: the manufacturer, authorised representative, importer and distributor roles, and the data each has to keep current under...
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A free sale certificate is one of those documents that gets requested at the last minute, when the container is already booked...
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The CE mark on an operating light looks identical whether the file behind it was built for the old MDD directive or...
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Electromagnetic compatibility — EMC — is one of the most misunderstood requirements for medical device importers. When a piece of electrical medical...
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MDSAP — the Medical Device Single Audit Program — replaces multiple country-specific audits with one audit recognized by five regulators: the US...
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Every medical device entering the United States market travels one of two main regulatory roads: the 510(k) premarket notification, or the premarket...
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Placing a medical device on the Great Britain market means working with two names that buyers hear constantly and rarely see explained...
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Importing medical devices into the European Union requires CE marking — a conformity mark that signals the product meets the EU Medical...
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For how the same class maps to the GB route, see our UKCA and UK MDR 2002 guide. An LED surgical light...
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The Core Difference: General QMS vs Medical Device QMS ISO 9001 is a general quality management system standard applicable to any organization,...
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