Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Medical device companies |
| Work | 510(k) preparation and related regulatory documentation |
| Rules and standards | FDA 510(k), where applicable |
We offer regulatory compliance services to Class I and Class II medical devices. Our services include ssistance with Establishment registration and device listing, GDUID, 510(k)(Premarket Notification), PMA(Premarket Approval), De Novo(Evaluation of Automatic Class III Designation), and HDE(Humanitarian Device Exemption).
Service information adapted from the original source ↗.
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