Our no obligation situation analysis will identify your specific regulatory requirements and a practical cost effective pathway to compliance.
Creating a 200~400 page submission is a daunting task. By getting to market faster you will more than pay for the cost of our services!
A fresh set of experienced eyes not only assures the required independence, but also identifies opportunities for improvement..
Device manufacturing, water, and sterilization specialists on call.
Our low overhead narrowly focused business model allows us to deliver high quality consulting services at an affordable price, 100% Client Satisfaction Guaranteed.
With 35 years of medical device industry experience we provide cost effective pathways to compliance by:
The FDA regulates over 1 trillion dollars' worth of products, which accounts for 22 cents of every dollar spent annually by American consumers.
The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.
1289 N. Fordham Blvd. Suite A-128 Chapel Hill, NC 27517 USA
Phone: 919.942.1634
Washington DC: 202.241.3407
