by Medisint | lip 15, 2021 | Blog
eCTD (electronic Common Technical Document) is a standard format of submitting documents of medicinal product’s dossier to Health Authorities (e.g., for Marketing Authorization). Submission of an electronic documentation (eCTD) is used in most European countries, even...
by Medisint | svi 31, 2021 | Blog
PRRC – New role required by MDR With coming into power of EU regulation 2017/745, a new role requirement is created for Manufacturers and Authorised representatives of medical devices. A wish for managing compliance with EU MDR resulted in creating the role of the...
by Medisint | svi 16, 2021 | Blog
Common practice of distributor/importers of medical devices is to perform changes in the packaging of medical devices. Many medical devices are available only in large packages so the need to separate the individual products according to the monthly requirements of...
by Medisint | svi 16, 2021 | Blog
As medical device become heavily regulated and fallowing all the requirement becomes time consuming, you may need the help of a consultant or a freelancer to speed up the processes and ensure regulatory compliance. There’s more than one valid reason to hire a...
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