IRC provides its expertise and experience in the areas of the Quality Systems regulation, Good Manufacturing Practices regulation and ISO quality systems for medical products. Whether you are an established manufacturer seeking an independent audit or a startup company with need to establish a compliant quality system for your operations, we have the ability to fulfill your requirements.
Our approach to quality systems is with an in depth understanding of what regulators expect. We help translate these expectations to fit into your culture and environment. We effectively and successfully view quality systems from the approach that it is dynamic and that one size does not fit all.
Quality System Services:
- US Quality Systems / Good Manufacturing Practices
- Audit and Inspection
- Systems Design and Analysis
- Corrective Action Plans
- Complaint handling
- SOP's, Documentation, and Implementation
- ISO/ EN Standards
- ISO 13485
- ISO 9001/EN 46001
- Strategic Review and Planning
- Pre Assessment Certification Review Audit
- System Design and Documentation
- Notified Body Selection and Coordination