In Vitro Diagnostic Devices – IVD
Get Your Device Approved
Our Regulatory Experts Are Second to None
We will write and submit your Q-submission, 510(k), De Novo, or PMA for your IVD to the FDA.
We will work directly with you to notify or obtain approval from your European Notified Body for your IVD device.
We will also prepare a global regulatory strategy for the registration of your IVD in other markets.
We will guide you step-by-step through the applicable regulations to be able to market your device wherever you are.
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Your journey to a successful regulatory submission and your LEAN Quality System begins here
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