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JB & Associates
P.O. Box 3900
Dana Point, CA 92629
Tel: 949/481-5713
Fax: 949/481-5745
Contact: Jim Barley
Year Established: 1992
No. of Employees: 3
E-mail: jim@jimbarley.com
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Description:
JB & Associates are quality and regulatory consultants that specialize in working with small and medium-sized medical device companies. The consultancy’s main emphasis is coordinating the design control process for R&D projects, beginning with preparation of the design control documents and including the submission of 510(k)s, IDEs, and PMAs to FDA. The firm also can provide assistance in clinical study protocol development, site selection, study implementation, and monitoring, and it can help medical device companies design, implement, upgrade, and monitor quality systems in compliance with the QSR and ISO 13485.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Good Manufacturing Practices/Compliance (53 companies)
- ISO 9000 (21 companies)
- Quality Management (21 companies)
- Regulatory Affairs (51 companies)
- Research & Development (35 companies)
