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.