Cardiolund have completed the ISO 13485 compliance assessment, and we now have a fully certified quality management system for developing medical device software. We have also CE marked the ECG Parser (and associated products). It is now certified as a Class IIa medical software for automated rhythm analysis of ECGs.
This implies that the ECG Parser is now certified as a standalone software for clinical use in applications such as categorisation, prioritisation, and screening, in particular screening for AF. Other important clinical uses include decision support, pre-processing for subsequent aggregation, ECG-related workflow improvement in user interfaces, drug response analysis, and database search applications.
The quality management system and product certifications are an additional benefit for our customers and their users, who can now be even more confident in the services and ECG analysis software we provide.