|
|
|
©2010, Regulatory Insight, Inc. All Rights Reserved.
FDA Submissions * Medical Device Clinical Studies and Performance Testing
Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.
Comprehensive worlwide regulatory consulting services.
The Principals at Regulatory Insight have over 40 years of combined experience with global regulatory submissions
and clinical studies to support those submissions. They know what it takes to get a medical device or IVD cleared, approved, licensed, etc. around the world.
Regulatory Insight maintains an up-to-date industry knowledge base, not only through traditional routes such as industry subscriptions,
but through its daily interactions with regulatory body staff around the world. In this way, Regulatory Insight is always current in the most effective ways
of getting products through each regulatory body review cycle in the least burdensome, least costly and least time-consuming manner possible.
Your company may choose to complete its own 510(k), PMA, Canadian Medical Device License Application, Technical File, Design Dossier, etc.;
however, you may want to know what options are available (e.g., Traditional versus Modular PMA), or what specific test data are needed
for your particular device submission. Regulatory Insight can provide guidance to your company in this regard, including conducting research on applicable regulations
and engaging in discussion with the applicable regulatory bodies to determine the specific needs for your device or IVD and the most efficient
regulatory path to attaining your goals.
Regulatory Insight can also provide submissions training for your company that covers the basic step-by-step approach to completing a medical device
market application. We can focus the training on the requirements for your specific device and explain the different strategies available to you to
get your product on the market in the fastest and most cost-effective manner.
FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions
FDA Registration Consultants | FDA Compliance Consultants | FDA Submissions | FDA Compliance | Medical Device Consulting | Training | Imports/Exports | Contact
