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The bibliography of a clinical protocol serves to demonstrate that the protocol is built on a solid foundation of existing…
The introduction of an article is meant to…introduce what has been done! But what structure can we give it?
Randomization is a statistical procedure that, when applied in clinical studies, assigns participants to different treatment groups randomly.
Inspection verification is a fundamental tool that companies can—and must—adopt to assess whether their Quality Management System (internal audit) or…
The risk management activity should be entrusted to a qualified team formed for this purpose, usually consisting of at least…
In any clinical study, researchers often encounter datasets with missing observations, commonly referred to as “missing data.”
According to the MDR Regulation, the technical documentation must be complete, well-structured, and contain sufficient information to demonstrate that the…
The data recording system aims to collect the results of all activities performed, all checks conducted, and the results obtained,…
The written presentation of a product can be defined as any activity aimed at describing and/or illustrating the product in…
The ISO 13485 standard establishes that the organization must conduct internal audits at planned intervals: it is good practice to…
The ISO 13485 standard for Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes establishes that the documentation…
Biological evaluation is a crucial aspect of medical device development. It should first be addressed during the design verification phase…
The Procedure Pack File for medical device systems and procedure packs, as well as the Technical Documentation for IVD kits,…
MDSAP è un programma di audit che consente la valutazione della conformità del Sistema di Gestione per la Qualità (SGQ)…
The regulatory review of a protocol or a clinical study report is a crucial step in the development and commercialization…
Planning clinical research is a well-structured process aimed at transforming an idea into clear, coherent, reliable, presentable, and contestable data.
I corsi di formazione di Clariscience
Le tematiche principali e più attuali relative agli affari regolatori e alla qualità di dispositivi medici e IVD, e al medical writing e alla comunicazione scientifica per l'intero mondo life science.
13 May 2025
ore 16:00
1 h
Gratuito
Zoom
Vedremo insieme le principali tecniche di analisi e perché il suo utilizzo potrebbe avere un valore strategico per i fabbricanti di dispositivi medici
Power class
Comunicazione scientifica
21 May 2025
ore 10:30
45 m
150€
Zoom
La ricerca sistematica di letteratura è il primo passo per ottenere, e poi analizzare, i dati clinici disponibili sul proprio dispositivo: come condurne di efficaci e a cosa prestare attenzione
22 May 2025
ore 11:00
1 h
Gratuito
Zoom
Quali sono le novità introdotte dal PPWR per i fabbricanti di dispositivi medici e IVD? Vediamo insieme l'impatto diretto per il settore medicale e come pianificare l'adeguamento ai nuovi requisiti
In collaborazione con ZPC Srl - Società Benefit
11 June 2025
ore 15:00
1 h
Gratuito
Zoom
Come affrontare la valutazione clinica per i dispositivi dell’Allegato XVI? Dal contesto normativo, passando per le principali differenze rispetto ai dm "tradizionali" fino a qualche indicazione strategica dm-specifica
Try Raqa Underground!
RAQA Underground is the interactive map that visually narrates regulatory affairs and quality assurance in the world of medical devices.
