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At BD Biosciences, we pride ourselves on our robust Quality Management System. Our manufacturing sites are not only accredited but also undergo regular audits by independent certification bodies, ensuring we meet the highest standards of quality and compliance. While maintaining the high quality standards for our own products, we also offer products that support our customers to comply with government regulations and requirements through features relevant to FDA 21 CFR Part 11 and IVDR compliant devices.
This dedication drives continuous improvement and operational excellence, positioning BD Biosciences as a trusted leader in the industry.
21 CFR Part 11
Discover how BD products like the BD FACSuite™ Application and BD Infinicyt™ Software facilitate compliance with these guidelines. Explore how BD supports our customers with built in features relevant to 21 CFR Part 11 compliance, including maintenance of data integrity and security with electronic signature and audit trail.
In Vitro Diagnostic Medical Device Regulation (IVDR)
Discover how BD Biosciences is aiding the transition from IVDD to IVDR with our IVDR-compliant solutions. Explore the impact of the new regulation, and uncover our expanding IVDR-compliant portfolio designed for delivering safe and effective IVD medical devices.