Quality Systems

Medical Device Regulatory Advisors, Inc. (MDRA) can assist your company with the following:

• Quality System Regulation (QSR) Compliance Audits
• Quality Manual and Procedure Preparation
• Quality System Improvement Programs
• Independent Supplier Approval Audits
• Design Controls Program Assistance
• Product Risk Analysis

The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use.

Recent changes to the regulation have made it necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide.

This regulation sets forth the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.