Quality Assurance & Regulatory


Lifecore’s quality systems ensure established processes and equipment are maintained in a validated state throughout their lifecycle. Our in-house validation experts ensure sterilization processes, controlled environments, equipment and cleaning processes are routinely monitored and revalidated to ensure their continued viability and reliability.

The entire Lifecore team is committed patient safety by complying with applicable standards, regulations and statutory requirements through Lifecore’s established quality system.

Lifecore’s quality system is compliant to the following:

  • 21 CFR 820 (FDA Quality System Regulation)
  • 21 CFR 210, 211 (FDA Good Manufacturing Practice)
  • EudraLex Volume 4 (EU Good Manufacturing Practice)
  • EN ISO 13485, Medical Devices – Quality Management systems – Requirements for regulatory purposes
  • Consolidated European Medical Device Directive 93/42/EEC
  • ICH Q7, GMP Guide for Active Pharmaceutical Ingredients

All lots are released by Lifecore QA and a Certificate of Analysis and Certificate of Compliance is issued after final batch record review is completed.

Any client and regulatory agency audits are managed by our QA and regulatory departments.

QA works closely with our clients to promptly respond to and investigate any client complaints.

The QA and regulatory staff, assisted by the product support team, manage client and regulatory audits throughout the lifecycle of the product.

Keeping all of these services in-house gives you a central point of contact and a smoother process for compliance.