Quality Systems. Quality Support.
RCRI also provides comprehensive Quality Systems support for FDA quality system regulation (QSR) and ISO compliance. We support our clients with:
- Integrating regulatory and quality strategies using risk-based approaches
- Designing and implementing quality systems
- Maintaining innovative quality strategies, flexible enough to address specific device nuances and designed to grow along with the device during the entire product lifecycle
- Researching and understanding regulatory body hot buttons to provide proactive risk-mitigation strategies to avoid regulatory sanctions.
From Fortune 100 companies to start-up innovators, our advisors have assisted with establishing design controls, performing audits and addressing compliance gaps. No matter your size, we can scale the quality system effort to your goals, products, and culture.
RCRI is your Expert regulatory consulting and quality systems partner.