content
The validation of medical device software represents the conclusion of the development process. It is important to clearly distinguish between verification and validation. Software validation serves to prove that the software fulfills its intended purpose. One aspect of this is the validation of usability (usability validation via formative evaluation). The seminar explains which regulatory requirements exist and how to implement them in order to achieve an approved medical device with manageable effort. Another aspect of software validation in medical technology is the validation of tools used there - also referred to as Computer System Validation (CSV). The seminar will also provide insight into this.
topic overview
- Introduction, terms and definitions
- Regulatory requirements for software validation in medical technology
- Product related: EU-MDR, IVDR, IEC 62304, IEC 60601-1 and IEC 82304-1
- Process/tool related: ISO 13485, ISO/TR 80002-2 and GAMP5
- Implementation of the requirements in a validation strategy for the respective partial aspect
- Joint processing of exemplary tasks and presentation of possible solutions (workshop)
target group
(Software) development managers as well as software architects and developers, but also product managers, employees of regulatory & clinical affairs and usability engineering experts.
previous knowledge
Basic knowledge of the product life and development cycle of medical devices and the relevant processes.
KONTAKT:
Online
