QUALITY SYSTEMS & REPORTING

Quality Systems & Reporting offers consulting Regulatory Affairs and ISO Quality Systems leadership to manufacturers and their vendors, with the following expertise:

Regulatory Affairs
Medical Device Manufacturers
FDA Design History File gap analysis, remediation and generation to 21 CFR 820.30.
EU Technical File gap analysis, remediation and generation to MDD and IVDD.
FDA Design Control process writing and compliance documentation.
Adverse incident/event investigation and reporting.

Quality Management Systems
Medical Device, Aerospace, Automotive & Environmental Firms
ISO Quality Management System process writing, registration, maintenance and renewal to ISO     9001, 13485, 16949, 14001 and AS-9100
Product, process and service performance analysis and improvement

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Please contact Quality Systems & Reporting today for a confidential discussion of your project and its timely execution to requirements.

Regulatory Affairs & Quality Systems Consulting

Craig A. White

President
949-933-8889 (Phone)
888-361-6592 (Fax)