FDA 510(k) Validation Suites
IEC-61508 ▪ FDA510(k) ▪ IEC-60601 IEC-62304 ▪ ISO-14971
Complete FDA 510(k) compliant suites of standards, designs, test code, test results, trace matrices and all related documentation for certification up through FDA/CDRH Class III medical devices.
With the ever increasing price of medical software development and testing,
you can now add the reliability and assurance of a thoroughly tested RTOS to
your product and still reduce your development and test time and expense.
The FDA 510(k) Validation Suites provide a complete set of tests and
documentation to prove the suitability of the software for medical products. The
Validation Suites are available for Real Time Operating Systems, Embedded File
Systems and TCP/IP Network stacks for most processors and compiler toolsets.
Click on the links for additional information on Validation Suites for specific components.
| Micrium | Interniche |
| µC/OS-II RTOS* | NicheStack |
| µC/FS File System | NicheLite |
| µC/TCP-IP Network stack |
The µC/OS-II RTOS Validation Suite is also available as a ready to use kit. Click this link for more information: µC/OS-II Validation Suite Kit.
Additional information and a collection of sample certification documents are
available upon request. Click on the following link to request these PDF samples
in zip file format: Validation
Suite Information Request Page