Navigating the complexities of the FDA 21 CFR Part 820 Quality System Regulation (QSR) can be challenging for medical device manufacturers. At Operon Strategist, we specialize in guiding businesses through the compliance process to ensure your quality management system (QMS) meets FDA standards.

Our services include:

QSR Compliance Consulting: Tailored guidance to help you meet FDA 21 CFR Part 820 requirements.

Quality Management System Design: Assistance in designing a robust QMS that aligns with FDA regulations.

Documentation & System Implementation: Support in developing and implementing critical documents and processes.

Training & Education: Comprehensive training for your team to stay up-to-date on FDA requirements.

FDA 510(k) & ISO 13485 Certification Support: Offering full-spectrum support for your regulatory needs.

With our in-depth expertise in FDA QSR regulations, we provide step-by-step assistance to ensure your medical device manufacturing process is compliant, efficient, and FDA-approved.

Why Choose Us?

Experienced Team: Our consultants have years of hands-on experience in the regulatory field.

Global Reach: We work with companies worldwide, helping them navigate regulatory hurdles.

Turnkey Solutions: From initial compliance assessments to final approvals, we cover all aspects of QSR compliance.

Let Operon Strategist be your trusted partner in achieving and maintaining FDA 21 CFR Part 820 compliance.