Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Medical device companies |
| Work | Review of intended use, technology and possible submission routes |
| Rules and standards | 510(k), IDE and other product-specific FDA routes |
HMC supports review of development requirements and potential submission pathways for the product.
For pharmaceuticals
We'll clarify what tests and standards you need to meet, meanwhile setting you up with a standard process to help bring your drugs to market. We also provide solutiosn for the following:
● Pre-IND and IND
● Submission before going to market
● Submitted first
● Clinical investigation.
● Global requirements to enter the market
For biological products
For biological products, discuss the applicable development and submission requirements with HMC:
● Pre-IND and IND
● Access is extended
● Submission to the market
● Send BLA
● Global requirements to enter the market
● Other prerequisites for getting your product to consumers
For medical equipment
Device type, availability of predicate devices, and technology all affect licensing and liquidation of medical devices. HMC will help you understand how and what to submit to the licensing authority. We also advise on the following:
● Requester type (investigational device exemption (IDE), 510(k), PMA, De Novo, HUD & HDE)
● Should you apply for the US Food and Drug Administration (FDA)'s Breakthrough Device Designation?
● Performance test request
● International performance standards
● Global requirements to enter the market
Service information adapted from the original source ↗.
Read the original website record