Development & approval according to MDR
The success or failure of a new medical software product is already fundamentally determined at the product development stage. The focus here is on the safety, performance and usability of the product. With this practical in-house training course, we would like to give you an overview of the key elements of the software life cycle based on IEC 62304 & the 21CFR820 (FDA). Our practical examples will help you to understand and implement the tasks during the entire product life cycle – from the idea to marketing.
The seminar contents
- Software as a medical device
– General regulatory requirements
– Delimitation issues (standalone, embedded software, medical apps, etc.)
– Typical approval issues - Software Life Cycle – Processes
– Regulatory requirements
– EU view (IEC 62304)
– US view (FDA Guidance Documents)
– Typical tasks and methods Verification and validation
your trainer
DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
