Read this article to understand a little more about FDA Quality System Regulation (QSR) 21 CFR Part 820 and the need for the FDA to adopt ISO 13485 certification for medical device manufacturers.
It’s time for the FDA to fully embrace ISO 13485
Watch this webinar and learn how visual management and process confirmation can help the performance of your main processes
Learning to See Using Visual Management & Process Confirmation
Casi di Successo
Atento Brazil advances in the digital transformation journey
Company offering CX solutions automates end-to-end processes
Watch this webinar and understand how ISO 56000 can help in managing innovation and intellectual property, while also organizing knowledge and managing ideas.
The ISO 56000 series of Innovation Management standards
Promuovere l'innovazione e il cambiamento organizzativo
Gestione dei Cambiamenti e dell’Innovazione – ICM
Watch this webinar and learn how to get the best out of your process mapping and its benefits.
Process Mapping and its Benefits
Read this eBook and learn important tips that will help you apply the FMEA tool to prevent risks and improve the reliability of your business.
FMEA: A complete guide to identifying and preventing risks in your company
Read this eBook and learn how technology can contribute to meeting the resolution on GMP for medical devices.
GMP: How to implement them in the medical device industry
We've gathered SoftExpert’s most popular articles on quality auditing. Get access to the best content in one place!
Audit in practice
See how process automation can facilitate digital transformation and contribute to improving your company's results.
Process automation: How to drive the digital transformation journey
The ESG concept is here to stay, and you can't be left behind. Read this eBook and learn more about this new sustainable reality.
ESG: The New Business Paradigm
Discover the key factors that the pension and retirement fund sector needs to cover to enhance performance of its activities.