- IEC 62304 Medical device software - software life cycle process
- Introduction to medical device software and device classifications
- The basics from ISO 14971 on risk management
- Introduction to IEC 81001-5-1 on security
- Agile and IEC 62304
Contact hours: 1 session, in total 8 hours, including breaks
MDSW challenges
Issued to
Hans-Jörgen Gunnarsson
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Credential Verification
Issue date: September 4, 2024
ID: 38957e0c-25fb-4311-9c30-abb5310af452
Issued by
Besser Visser AB
Besser Visser AB is a consulting firm active in the medical device industry. It primarily focuses on software. Check out our training offers provided together with Medical Device HQ!
Type
Course
Level
Introductory
Format
Offline
Duration
1 days
Price
Paid
Description
The course included the following topics: Medical device generics: - Generic “stuff” - Introduction to MDSW, classifications and risk IEC 62340: - Scope and definitions - Software risk management - Development planning - Configuration management - SOUPs - Requirements - Architecture - System testing - Release - Problem resolution - Change control Agile - Defining the scope - TIR45 and the layered approach
Skills
IEC 62304
Medical Devices
Risk Management
Software Development