Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide regulatory approvals and compliance services (GMP, QSR) for product development and manufacturers of medical products (US FDA, EU, Canada).
Qware Riskmanager is the market leading quality management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971.