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ÚLTIMAS NOTICIAS
A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
É com grande satisfação que anunciamos que a Formiventos é, pelo quinto ano consecutivo, empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2026, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira. Este feito é motivo de...
Electronic Submission Template for Premarket Approval Applications (PMAs)
This guidance describes the technical standards associated with preparation of the electronic submission template for PMAs/PMA supplements that enable submission of the Designated Application Types solely in electronic format. This does not include PMA Modules and...
MDSAP Technical Review and Recognition Decision Procedure
The Medical Device Single Audit Program (MDSAP) has released an updated version of its Technical Review and Recognition Decision Procedure (MDSAP AS P0017.005), effective 1 September 2026. This procedure applies to a technical review process that is to occur...
Essential Principles and Content of Predetermined Change Control Plans. Final Document
The purpose of this document is to share high-level principles on the use of PCCPs as a way of authorizing certain planned medical device software modifications for which regulatory authorization is otherwise required. Additionally, it aims to identify the...
Comprometidos com a qualidade e a inovação.
































