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For medical devices and IVDs
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management systems
For medical devices and IVDs
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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.
Speed webinar
Comunicazione scientifica
19 November 2024
ore 15:00
1 h
Gratuito
Zoom
Offriamo una panoramica dettagliata dei processi e delle normative chiave che regolano gli studi clinici sui dispositivi medici. Presentiamo casi studio e best practices, offrendo esempi concreti per migliorare la...
28 November 2024
ore 11:00
1 h
Gratuito
Zoom
La norma UNI EN ISO 11135:2020 definisce i requisiti da soddisfare per lo sviluppo, la validazione e il controllo del processo di sterilizzazione di routine dei dispositivi medici. È necessario...
In collaborazione con Sterox parte di SDS Group
5 December 2024
ore 10:30
1 h
Gratuito
Zoom
Con il Regolamento UE 2017/745, tutti i fabbricanti di dispositivi medici devono adottare un sistema di gestione per la qualità che soddisfi requisiti rigorosi.
11 December 2024
ore 10:00
2 h
350€
Zoom
Il Regolamento UE 2017/745 sui dispositivi medici ha mantenuto la definizione di “dispositivo su misura” già presente nella precedente direttiva, distinguendo chiaramente questa categoria dagli altri dispositivi medici.
Try Raqa Underground!
RAQA Underground is the interactive map that visually narrates regulatory affairs and quality assurance in the world of medical devices.
