J Blane, LLC

J Blane, LLC provides regulatory consulting services to medical device and biologics companies in all stages of growth. Services include, but are not limited to:
-Development of worldwide regulatory strategies
-Creating FDA PMA, IDE & 510(k) submissions
-Creating FDA Q-submissions
-Developing responses to agency requests for additional information
-Leading meetings with worldwide regulatory agencies
-Creating and updating European Union (EU) Design Dossiers, Medicinal Substance Dossiers, Clinical Evaluation -Reports and Technical Files

Areas of expertise include: cardiovascular devices, craniomaxillofacial devices, dental devices, drug/device combination products, human tissue products, injection devices, software as a medical device (SaMD), medical imaging devices, orthopedic devices, spinal devices and vascular devices.

Company’s Keywords:

spinal devices, orthopedic devices, craniomaxillofacial devices, medical devices, medical imaging devices, drugdevice combination products, human tissue products, software as a medical device, cardiovascular devices, dental devices, biologics, injection devices, vascular devices, regulatory affairs consulting