Independent Quality Systems Associates, Inc.
Roy R. Rupe, President
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Medical
Device Regulatory Compliance Services
o
Comprehensive and objective
GMP Audits of Medical device manufacturers, Contract sterilizers, Vendors and
R&D sites, under the new Medical Device Quality System Regulation, using
FDA inspectional methods and procedures.
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Specializing in Software
Quality and Design Controls Assessments.
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Counseling in effective
communications with the FDA, navigating FDA inspections, providing assistance
in drafting correspondence to the FDA such as responses to Inspectional
Findings, (FDA-483s), Warning letters, Corrective Action Plans, etc.
o
Training and guidance for
Regulatory and QA staff in FDA inspectional procedures and management of FDA
inspections.
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Training at all corporate
levels on the new Quality System Regulation including the new Design Control
requirements.
Contact Information
43 Cambridge Trace Ormond Beach,
FL 32174-2471
Phone: (386) 671-1646 Fax: (386) 671-1042
E-mail: IQSA@iqsa.net