Regulatory Affairs & Quality Systems Consulting
ISO, Medical, Audits, Process Documentation, Standards, Regulations

REGULATORY AFFAIRS

Do your Design History Files comply with FDA requirements? Does your Design Control process prompt for and record that compliance? Do your Technical Files for the European Union comply with the Medical Device Directive (MDD) or the In vitro Diagnostic Directive (IVDD)? Has a customer filed an adverse incident or event report with a regulatory agency?

Quality Systems & Reporting

Performs gap analyses and remediates existing FDA Design History Files and EU Technical Files.
Guides new products through the regulatory documentation process.
Creates product design, development and design control processes that prompt for and record compliance to all requirements.
Performs tactful yet meticulous investigation of adverse incident or event reports to determine their reportability to national or international regulatory agencies.



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

Regulatory Affairs & Quality Systems Consulting
Quality Systems and Reporting - Craig White

Craig A. White

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

Quality ISO and Medical Audit

 

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