Through accredited testing and certification, TÜV Rheinland verifies compliance with IEC 62304, IEC 81001-5-1 and IEC 60601-4-5, MDR, IVDR, and FDA requirements. Independent evaluations reduce compliance risks and demonstrate conformity before market entry.

Our cybersecurity testing services – including penetration testing, vulnerability scanning, fuzz testing, and Threat Analysis and Risk Assessment (TARA) – confirms the resilience of medical software against threats to patient data and device performance.

Structured verification and validation testing can be aligned with MDR, IVDR, and FDA submission timelines. This supports efficient regulatory approval across multiple regions and helps manufacturers bring innovations to market more quickly.

TÜV Rheinland delivers impartial reports with clear findings, compliance status, and identified risks. These provide manufacturers with a reliable basis for decision-making at every stage of medical software development.

With accredited labs and regulatory specialists worldwide, TÜV Rheinland conducts assessments that reflect regional requirements while ensuring compliance with international standards.

Network connected medical software enables life-saving innovations, but it also faces constant cybersecurity threats. Any software-driven device – from wearable health monitors to networked hospital systems – can be vulnerable to cybersecurity threats. Independent testing to the highest standards by experienced experts allows our customers to identify and mitigate the discovered weaknesses and vulnerabilities in their products with ease.