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Registo Investigação e Tratamento de RECLAMAÇÕES : “Muito útil para melhorar os processos já implementados “
No passado 20 de março, decorreu em Lisboa uma nova edição da formação exlusiva da Formiventos sobre " Registo Investigação e Tratamento de RECLAMAÇÕES de QUALIDADE e de DISTRIBUIÇÃO", conduzida por Sónia Rei, Associate Director Operations, na Hikma A iniciativa...
ISO 20417:2026 – Updated Guidance on Medical Device Information – The second edition of ISO 20417:2026 (Medical devices – Information to be supplied by the manufacturer) has just been published.
This edition cancels and replaces the first edition (ISO 20417:2021), which has been technically revised. ISO 20417:2026 sets out requirements for the information that manufacturers must supply with medical devices and their accessories, including labelling,...
COMMISSION DELEGATED REGULATION (EU) …/… amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations C/2026/1798 final
Well established technologies (WET) are relatively simple devices, having common and stable designs with little evolution, well-known safety and clinical performance characteristics and a long history on the market. Criteria for identifying WET have been set in...
Progressing EMA’s PRIority Medicines scheme through new pilot features
Report on the experience with the new PRIME features following the 5-year review of the scheme to support the development of medicines targeting unmet needs This report presents the findings from a two-year pilot (April 2023–March 2025) to assess the...
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