Certified verification for medical device software.
The same TÜV SÜD certificate that covers ASIL D also applies to IEC 62304.
Industry pressure, made visible.
Regulatory pressure from FDA and EU MDR keeps increasing. Evidence from requirement to code is mandatory.
SOUP and growing AI content in medical devices make evidence harder to produce.
Smaller medtech teams often do not have dedicated verification specialists like large automotive OEMs.
IEC 62304 inside the same certified process.
IEC 62304 is included in the TÜV SÜD certificate. Certificate and report can reduce separate qualification work, especially for smaller medical software teams.
Direct ALM and PLM connections support evidence chains instead of spreadsheet-based gaps.
Deterministic verification supports evidence when SOUP or AI-generated content raises uncertainty.
One workflow can cover hand-written code and model-based parts where both exist.
Certified proof bridge.
The proof story is the certificate bridge: the certificate that covers ASIL D also applies to IEC 62304.
Fits the engineering environments this industry actually uses.
See BTC TestStack on IEC 62304.
Bring your codebase and standard context into an evaluation with our engineers.