Ready for FDA 510(k)?

Our experts will help get your medical device approved.

Ensure cybersecurity integrity.

Meet IVDR/FDA stringent standards throughout design, development, deployment, and documentation.


We understand the process.

Find out more.

softwarecyber 510k word stack

Minimize delays.

Has your IVD software just turned into a medical device?

SoftwareCyber 510(k) regulatory experts can help you assure compliance to current international IVDR and MDR regulations.

Want to market your IVD or medical device software?

Learn how we help with 510(k) FDA submission.

Concerned complying with the new IVDR and MDR software requirements will hurt your business?

Proven software design and development framework, and, software development experts will help remove friction and boost product development during the shift.

Meet coming IVDR and MDR software regulatory requirements.

Contact us
for a free list of software documentation requirements to meet the new IVD and MDR regulatory requirements.