FDA 510(k) regulatory strategies were developed and implemented for multiple devices, from screws to thoracic products. We provided detailed guidance to our clients on regulatory documentation and compliance activities, including advice on validation and risk management. We completed and submitted 510(k) application per requirements. We served as liaisons for FDA interactions and gained clearance for all devices.
Health Canada Licenses:
We gained Canadian medical device license approval for over a dozen orthopedic products. We determined device classification, submission strategy, compiled application data and wrote all applications. We communicated with Health Canada application reviewers and resolved all additional information requests to successfully obtain license approvals. We also positively resolved and reversed one reviewer’s initial license rejection, by using Health Canada’s rarely used appeals process.
Quality Management System:
Initial Quality Management System (QMS) documentation was created for a small startup company. The QMS was implemented and our leadership led to a successful FDA inspection and ISO 13485 Certification.
Technical File Documentation:
Medical product technical files were created and maintained, leading to European Union (EU) Notified Body approval. We ensured all required content was documented and clearly communicated to the medical device company’s Notified Body and Authorized Representative in the EU, allowing for CE Marking of these products.
We audited medical device labeling and marketing materials, providing guidance on regulatory discrepancies for resolution. We educated the clients on the regulatory requirements in order for each client to ensure future compliant labeling and marketing documentation.
Instruction on establishment registration, device listing, design control, technical file, clinical data and global testing requirements were provided to our clients to improve their understanding and efficiency of their product development activities.