CASE STUDY

Validation & Certification Strategy for Company Receiving SBIR

Client

Medical device company

Services

  • Validation and Certification Strategy
  • Customer Liaison
  • 510K Support Materials Development

Results Summary

  • Business development activities with key CAP advisors

Challenge

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.

 

Solution

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.

Results

Business development activities with key CAP advisors from leading medical device companies followed from our efforts.

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