Regulatory Submissions and Service

Assistance in getting your device through regulatory hurdles so you are able to market in the US and abroad.

• FDA clearance (510(k), 513(g) and Pre-IDEs) and FDA approval (PMA and IDEs)
• Health Canada Medical Device Licence applications
• FDA Establishment Registration and Product Listing
• CE Marking
• Import/Export Requirements, FDA Certificate to Foreign Government (CFG)
• Initial Importer
• US Agent and Official Correspondent to the FDA

Clinical Trials

Pre-market and post-market studies are often necessary to legally market your device.

• Study strategy, design and protocol development
• Program placement, program management and study monitoring
• Biostatistics
• Reporting

Quality Systems Development

A quality system is required to ensure the methods used in, and the facilities and controls used for the design, manufacture, packaging, labeling, and storage of all devices are compliant with current regulations. A quality system must be in place before brining your device to market.

• FDA Quality System Requirements (21 CFR 820)
• Unique Device identification (UDI)
• International standard for quality management systems (ISO 13485)
• EU CE Marking
• Canada Medical Device Licence (CMDCAS)

Areas of Special Expertise

• Orthopedic implants (i.e. spinal, restorative and reconstructive devices)
• Dental implants and restorative materials
• Bone graft substitute materials
• Soft tissue implants
• Coordination of materials testing, component testing, and characterizations
• Product and material biocompatibility
• Sterilization and cleaning validation
• Bioceramics, calcium phosphates and bioresorbable polymers