Quality & Regulatory

Quality & Regulatory Compliance

Michigan Diagnostics maintains the highest quality standards for all our products. Our commitment to regulatory compliance ensures that researchers and clinicians worldwide can trust our reagents for critical applications.

Regulatory Approvals

🇺🇸 FDA (United States)

Many of our products are FDA-approved for clinical diagnostic use in the United States. We maintain strict compliance with FDA 21 CFR Part 820 Quality System Regulations.

🇪🇺 CE Mark (European Union)

Products marked with CE certification meet European Union health, safety, and environmental protection standards for in vitro diagnostic medical devices (IVD Directive 98/79/EC).

🇨🇳 Chinese FDA (CFDA)

Select products are registered with the China Food and Drug Administration for distribution in Chinese markets.

📋 ISO Compliance

Our manufacturing processes follow ISO 13485 quality management system standards for medical devices and in vitro diagnostics.

Quality Assurance

Manufacturing Standards

  • All products manufactured in our ISO-compliant facility in Royal Oak, Michigan
  • Raw materials sourced from qualified suppliers with full traceability
  • In-process quality control checks at every manufacturing stage
  • Final product testing including purity, potency, and stability analysis
  • Environmental monitoring for cleanroom manufacturing areas

Documentation

Every product batch includes:

  • Certificate of Analysis (COA): Batch-specific test results confirming product specifications
  • Safety Data Sheet (SDS): Comprehensive safety and handling information compliant with GHS standards
  • Product Datasheet: Technical specifications, storage conditions, and application guidelines
  • Regulatory Certificates: FDA, CE, or other applicable certifications upon request

Storage & Stability

All products are tested for stability under recommended storage conditions. Expiration dates and storage requirements are clearly marked on product labels and documentation.

Product Complaints & Support

If you experience any quality issues with our products, please contact our technical support team immediately at [email protected] or (248) 435-4472. We maintain a comprehensive complaint handling system and will investigate any reported issues promptly.

Research Use Only (RUO) vs. Clinical Use

Important: Unless explicitly stated as FDA-approved or CE-marked for clinical use, our products are labeled “For Research Use Only” (RUO) and are not intended for diagnostic procedures on human samples outside of research settings.

Questions about regulatory compliance?
Our regulatory affairs team can provide certificates, compliance documentation, and guidance for your specific market requirements. Contact us at [email protected]