Accelerating FDA Clearance for Next-Gen Blood Glucose Monitoring Device

Accelerating FDA Clearance for Next-Gen Blood Glucose Monitoring Device

We helped client with the FDA 510(k) Clearance for our client developing a new innovative Blood Glucose Monitoring Device.

MDSAP Regulatory Support For Harmonized Compliance

We helped the client to be compliant to all the regulatory requirements for MDSAP (Medical Device Single Audit Program).
clinical evaluation report for Cochlear Implant or co

CER Requirements for a Cochlear Implant

We helped the client to create a compliant and accurate clinical evaluation report (CER) for a Cochlear Implant. Explore our journey and how we overcame all challenges.