Omnee Strategic Solutions Information

Summary

Our goal is to ensure that your medical device not only meets regulatory standards but also achieves successful market entry and sustained compliance.

Our specialists bring over a decade ...Show more

Employees Size

1-10 employees

Specialties

Medical Device Regulatory Affairs, 510(k), PMA, EU MDR, Regulatory Strategy Development, Pre-Market Submissions , Post-Market Compliance, Q- Submissions, De Novo, IDE, STEDs, Electronic Common Technical Document (eCTD), Pre-Submissions