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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