Design Control in the field of Medical Devices
Produktnummer 08-059-24-EN
- Training Präsenz / Virtuell
- Virtuelles Klassenzimmer
- Intermediate
- EN
Jetzt verfügbar - Neue Termine für 2027
Details
The success or failure of new medical devices is already fundamentally determined at the product development stage. The focus is not only on safety, but also on usability and efficiency. This seminar clarifies the essential elements of instrument design control following 21 CFR 820 (FDA), ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). You will learn the basic terminology and practical methods and examples of its use will be provided. You will always keep an eye on the entire product life cycle, from the product idea to the end of product marketing.
Inhalte | Content
Day 1:
- Basics of design control
- Overview of the current status of legislation (21 CFR 820) and standardization (ISO 13485:2016)
- Design and development planning
- From user needs to design input
- Design verification, results and validation
- Design transfer
- Design reviews
Day 2:
- Implementation-oriented workshop to create the essential elements of a DHF using a real example from the field of non-active medical devices
- User needs and their implementation in design input
- Design and development plan
- Design verification and validation
- Statistical sampling plans
- Design change management
- DHF (Design History File) and Design Development File
- Dealing with external and legacy documentation
Duchführende Akademie | Executing Academy
Alle Online Termine dieser Veranstaltung werden von der TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainings gelten daher zusätzlich die Allgemeinen Geschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehen wir Ihnen gerne unter [email protected] zur Verfügung.
