Validation & Certification Strategy for Company Receiving SBIR
Medical device company
- Validation and Certification Strategy
- Customer Liaison
- 510K Support Materials Development
- Business development activities with key CAP advisors
For one of our smaller clients, our teams developed a validation and certification strategy for a company receiving an SBIR to develop an innovative immunoassay reader leveraging SARs and Spectroscopy science.
We sought and obtained participation in the NIH Commercial Assistance Program (CAP). The Plazabridge Group team attended the conferences and created the necessary documentation supporting the NIH program. Final presentations and reports were delivered in Washington, D.C. to NIH senior managers. Our team also assisted the company in developing 510K support materials and consulted on the execution.
Business development activities with key CAP advisors from leading medical device companies followed from our efforts.
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