Quality Matters
At MVE Biological Solutions, quality and compliance are foundational to everything we do.
Our commitment to product safety, reliability, and regulatory integrity is demonstrated through robust quality systems and adherence to global standards and regulations.
Understanding Regulations vs. Quality Systems
It’s important to distinguish between regulatory frameworks and quality system standards:
FDA Regulations (21 CFR Parts 800–899)
These are regulatory requirements for medical devices in the United States. Within this set, 21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines the specific requirements for quality systems. Although often referred to as a “quality system,” it is technically a regulation that mandates the structure of a quality system for compliance with FDA regulations.
Learn more about MVE’s FDA Registration.
MDD & MDR (EU Directives and Regulations)
The Medical Device Directive (MDD) and its successor, the Medical Device Regulation (MDR), are regulatory frameworks governing medical devices in the European Union. Like FDA regulations, they include provisions that mandate certain quality system elements, but they themselves are not quality systems.
ISO 13485
ISO 13485 is the internationally recognized quality management system (QMS) standard specifically designed for medical device manufacturers. Unlike the FDA or EU regulations, ISO 13485 is a quality system standard, not a regulation. It provides a framework for consistent design, development, production, installation, and delivery of medical devices that meet customer and regulatory requirements.
MVE’s Current Certifications and Compliance Status
✅ FDA Registered
MVE facilities are registered with the FDA, and our products are officially listed. We comply with all applicable Code of Federal Regulations (CFR) related to medical devices.
✅ Certified to ISO 13485
MVE maintains certification to ISO 13485, ensuring our quality management system meets rigorous international standards for medical device manufacturing.
✅ MDD Certified
We are currently certified under the European Medical Device Directive (MDD), which enables us to market our products throughout the EU.
🔄 Transitioning to MDR
We are actively working toward full compliance with the Medical Device Regulation (MDR). Although not yet fully regulated under MDR, our teams are diligently aligning our systems and documentation to meet all MDR requirements.
Our Commitment
We are dedicated to continuous improvement, regulatory compliance, and delivering exceptional quality across our product lines. As the regulatory landscape evolves, so too does our Quality System, ensuring we remain a trusted partner for critical cryogenic and biological storage solutions worldwide.