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 Details
- Employees
- 1
- Founded
- -
- Address
- 2400 Postal Blvd., Flagstaff,arizona 86004,united States
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- https://jblaneconsulting.com/
- Keywords
- regulatory affairs consulting, medical devices, biologics, 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, vascular devices.
- HQ
- Flagstaff, Arizona
- Competitors
J Blane, Llc Questions
J Blane, Llc's website is https://jblaneconsulting.com/
J Blane, Llc's LinkedIn profile is https://www.linkedin.com/company/j-blane-llc
J Blane, Llc has
1 employees.
View email and phone details for 1
employees at J Blane, Llc.
J Blane, Llc's industry is
Medical Equipment Manufacturing
J Blane, Llc's categories are Medical Equipment Manufacturing
J Blane, Llc's founding year is 2018
