With stringent regulatory compliance for medical devices and software, the role of remediation is increasingly being observed as a key strategy towards product success.
Towards compliant design and development
As part of remediation, our teams apply industry defined standards in software design, and make sure that all evolving regulatory protocols and legal guidelines are complied with.
Our experts meticulously examine and pinpoint any gaps in your software development process. They resolve these issues by working closely with your teams. We address safety and performance concerns, technical documentation and take up US FDA / EU MDR regulatory compliance documentation and submissions.
