Broad Regulatory Support For a G.I. Device Start-up Company
The Client is a start-up medical device company intending to develop and manufacture products in the gastrointestinal therapeutic area. Principals in the company are business executives and engineers, who are unfamiliar with FDA's regulatory and quality system requirements for medical devices. The company formed a strategic marketing/sales partnership with a division of a major Fortune 500 medical company.
- Client management realized that expertise was required in regulatory, quality management systems, clinical and manufacturing in order to satisfy FDA medical device clearance and compliance milestones from the strategic partner.
- Anson Group was chosen by the client to provide the required experience, flexibility and knowledge to the project.
The Anson Group Solution
Anson Group assigned a team of regulatory and quality consultants that functioned as an integral part of the client’s management team. This team:
- Created a basic design control and manufacturing quality system
- Defined and developed product labeling
- Developed regulatory strategies for FDA and EU clearance
- Developed clinical strategies to support regulatory clearance
Key Accomplishments (6 months after project initiation)
- The Anson Group supported ISO certification and CE marking for a product now in European Union distribution.
- The Anson Group defined and developed a regulatory strategy for a niche product in the GI area, resulting in a 510(k) clearance.
How The Anson Group has benefited the client:
- By incorporating Anson consultants onto the management team the client was able to meet the regulatory and quality system requirements imposed by the strategic partner, without incurring significant overhead costs.
- A revenue stream was enabled based on the clearance to market a "niche market" device in the EU and the US.