Certificates

Medical Devices: Quality Management Systems Undergoing Active Implementation & Certification

To better serve our partners in the medical device, life sciences, and clinical diagnostics sectors, ACI is currently in the process of implementing and achieving ISO 13485 certification.

• Our Commitment: This upcoming certification reflects our transition toward a highly formalized quality management system (QMS) specifically tailored to the medical device industry. We are actively aligning our manufacturing, documentation, and risk-management processes with these rigorous international medical standards.
• The Value to You: Our path to ISO 13485 ensures that we speak the same regulatory language as our medical OEM customers. It guarantees complete traceability, stringent risk assessment, and unmatched process control for critical medical-grade fluidics and precision components.

Precision performance shouldn’t come at the cost of environmental safety. ACI strictly adheres to RoHS directives, which restrict the use of specific hazardous materials in the manufacturing of our components and assemblies.

• Our Commitment: We verify that all of our fluidic seals, precision components, and sub-assemblies conform to the latest RoHS standards, limiting hazardous substances like lead, mercury, and cadmium to levels well below legal thresholds.
• The Value to You: Whether you are integrating our components into analytical laboratory instruments or complex industrial systems, you can integrate ACI products with complete peace of mind, knowing they meet global hazardous substance restrictions.

At ACI, environmental stewardship and chemical safety are foundational to how we source and manufacture our precision components.

• Our Commitment: We fully comply with the European Union’s REACH regulation, ensuring that all materials used in our manufacturing processes, including our advanced technical ceramics, synthetic sapphire, and specialized polymers, are monitored, registered, and completely free of Substances of Very High Concern (SVHC).
• The Value to You: Working with a REACH-compliant partner guarantees that your supply chain remains safe, sustainable, and fully compliant with stringent global environmental standards.