
Client Name
Edgecare
Industry : Medical Devices
Profile
Edgecare is an innovative healthcare company specialising in ultrasound-based solutions.
Business Challenge
To achieve FDA 510(k) clearance for its ultrasound bladder scanner, Edgecare needed a trusted cybersecurity testing body and expert guidance to meet regulatory requirements, build internal knowledge, and develop cybersecurity guidelines — all within a tight timeline.
Our Solutions
Since October 2023, the FDA has officially mandated that cybersecurity and penetration testing documentation is mandatory for the approval. As a result, many manufacturers have recently received requests for additional information regarding cybersecurity from the FDA, which has become a major hurdle in the approval process.
Through TÜV SÜD’s high-quality penetration testing services, clients are able to address cybersecurity-related deficiencies effectively.
Business Benefits
TÜV SÜD offers penetration testing and test reports that are designed for FDA and EU MDR conformity assessments. Through our Medical device expertise, we can guarantee effective and fast testing procedures. Our penetration tests and test reports have helped clients receive FDA approval.