An independent, FDA-recognized 3P510k Review Organization under the U.S. FDA CDRH 510(k) Third Party Review Program.
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Academic & ecosystem partners.

Collaborations that support regulatory science across the medical-device ecosystem — kept strictly separate from any review engagement.

Academic & Regulatory Science Partners

Academic collaborations that support medical-device regulatory science and readiness.

IIT BombayAcademic collaboration in medical-device engineering and regulatory science.
HTIC — IIT MadrasHealthcare Technology Innovation Centre; collaboration on medical-technology development.

MedTech Ecosystem Partners

Innovation-ecosystem collaborations across the medical-device landscape.

T-Hub, HyderabadInnovation ecosystem collaboration.
Global HealthXMedTech ecosystem collaboration.
Impartiality: Partnerships have no influence over eligibility determinations, reviewer assignment, review findings or regulatory recommendations. Collaborations are educational and do not involve submission authorship or regulatory advocacy.