The PaxMed International team has the qualifications and experience to help bring your device to market. We offer a high-integrity approach to the most daunting challenges for a medical device manufacturer: regulatory product review and regulatory compliance.
We have excellent, long-standing working relationships with FDA and other regulatory bodies ensuring that your submissions are fairly reviewed and your quality systems are properly prepared.
Our services include:
Regulatory Submissions and Services
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)
- FDA Establishment Registration and Product Listing
- CE Marking
- Import/Export Requirements, FDA Certificate to Foreign Government (CFG)
- Initial Importer
- Official Correspondent and US Agent to the FDA
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
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
- 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