inden Kobalt Software

Helps Medical Device manufacturers integrate applicable standards and guides them in their process

Certify smart tools identifies the standards requirement applicable to the Medical Device and automatically creates the corresponding risks and technical requirement.
It respects the methodologies imposed by the ISO 14971 and IEC 62366 and creates standards reports in line with the expectations of testing laboratories and auditors.
Thanks to its real-time traceability management, from normative requirement to proof of compliance you will have immediate impact analysis.
Certify is a user friendly tools that will help you optimize, control and follow your certification process.

Always available and up-to-date in Azure.