Medical Device QSR Consulting

Hack & Associates can  help you stay compliant with FDA Quality System Regulations (QSR) by provide quality system regulation documents (as per 21 CFR  Part 820).  We can help draft, review, and modify quality system documents such as:

- Medical Device Reporting (MDR) Procedures

- Complaint Handling Procedures

- Adverse Events

- Device Master Record (DMR)

- Design Transfer

- Design Validation

- Design Review

- Functional Design Requirements

- Project Quality Plan

- Change Management

- Risk Management

- Supplier Controls /Quality

- Purchasing Controls

We also assist with establishment registration and listing of both domestic and foreign manufacturers, import, and transfer.