MCRA

 Contact Information: 1331 H Street, NW
12th floor
Washington DC 20005
United States
202.552.5800

 Company Type: PRIVATE
 Company Description: The true value of MCRA is the integration of five business value creators (intellectual property, regulatory, clinical, reimbursement, and quality assurance).

MCRA prides itself on being a "one-stop-shop" for any company that would like to commence, continue or complete its technology's path to and beyond commercialization.

The end result is a single source of responsibility, creating efficiencies in accountability and time management.
 Website: http://www.mcra.com
 Related Resources:
 
    White Paper
Pre-Clinical Testing of Spinal Implants: Safety Versus Substantial Equivalence
Historically, the differences between the performance data threshold necessary to earn IDE approval versus the threshold to get 510(k) clearance has been very simple because most devices were clearly either class II or class III, where their design could clearly distinguish their intended use. However, a new trend is changing the landscape.

read more...


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