Quality and regulatory

Our commitment​

Compliance

Documentation and support​

Customer-centric quality​

Our commitment

At Applied Cells Inc. the quality is central to our approach in product development and customer support. Our mission is to empower researchers and clinicians by delivering high-performance solutions developed with a focus on reliability and alignment with recognized industry guidelines.

That’s why our quality and regulatory compliance are embedded into our design, manufacturing, and service processes. Please note: all our products are intended for Research Use Only (RUO) and are not to be used in therapeutic or diagnostic procedures.

Compliance

Our operations and product design align with the following global regulatory frameworks and quality standards:

  • ISO 13485:2016 certified Quality Management System, download the certificate
  • 21 CFR Part 11 compliant software with Audit Trail
  • CE (EU conformity)
  • UL, RoHS, and REACH
  • GMP reagents
  • Sterile Fluidic Kits satisfying ISO 10993-5:2009, ASTM D4169 DC13, ISO 11607 and ISO 11737-2:2019, download the certificate

We understand the importance of working in highly regulated environments in clinical therapy, diagnostics development and life science research. Our products are built with traceability and robust documentation to support audits.

Documentation and support

We provide certifications and technical files upon request and support customer audits. Our team is ready to provide documentation, including:

  • Certificate of Analysis
  • Technical Datasheet
  • Audit Trail exports

Customer-centric quality

We focus on:
• Understanding and anticipating customer and regulatory requirements
• Ensuring the reliability and safety of every product we deliver
• Providing documentation that supports customer-led validation activities
• Maintaining a culture of continuous improvement and innovation

We believe that developing high-quality products aligned with industry expectations is only half of the story — the other half is supporting you in achieving your goals. If you operate in a regulated environment or require specific documentation for audits or validations, our quality team is here to help.

Contact us

To request quality documentation or schedule an audit, contact us at quality@appliedcells.com.

Contact us