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.
Schedule a Free Consultation
Your journey to a successful regulatory submission and your LEAN Quality System begins here