QUALITY
When software is used for diagnostic purposes, it is regarded as a medical device according to European legislation, and must therefore meet stringent quality requirements.
The following RVC products are classified and approved as medical devices:
- RVC Clinical Assistant; Medical device Class IIa, MDD certified
- RVC Clinical PACS; Medical device class IIb
- RVC Clinical Insight; Medical device Class I, MDD certified
- RVC SKI (endoscope button interface); Medical device Class I, MDD certified
RVC Medical IT B.V. is ISO 13485:2016 certified.
