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J Blane, LLC: Our Commitment, Services and Expertise
Our Commitment
J Blane, LLC is committed to providing personalized and affordable regulatory guidance and services to medical device and biotechnology companies in all stages of growth. It is our commitment to empower our customers with an understanding of regulatory agency expectations. As part of this commitment, personalized training is always included with any service to help you make educated decisions for your company in the future.
Our Services
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
Expertise
Areas of expertise include:
- AI-enabled devices
- Cardiovascular devices (occluders, shunts, stent grafts)
- Clinical trials (IDEs, INDs)
- Craniomaxillofacial devices
- Cybersecurity requirements
- Dental devices
- Drug/Device combination products (auto injectors & sterile injectables)
- Endoscopic devices
- Endoscopic reprocessing devices
- Human tissue products (HCT/Ps)
- Injection devices
- Intraocular lenses
- In Vitro diagnostics
- Medical device software
- Medical imaging devices
- Neurovascular devices
- Orthopedic devices
- FDA Pre-submissions
- Software as a medical device (SaMD)
- Spinal devices
- Sterilizers
- Vascular devices
Certifications
