At Aprios, quality and trust are built into everything we do. Our certifications demonstrate our commitment to consistent processes, regulatory compliance, and the safety and reliability of every component we produce.
ISO 9001: Quality Management
Aprios operates under an ISO 9001-certified Quality Management System—our foundation for continuous improvement and customer satisfaction. This certification reflects our disciplined approach to process control, documentation, and corrective action. It ensures that every part we produce, from prototype to production, meets the same rigorous standards for performance and precision.
ISO 13485: Medical Device Manufacturing
Our ISO 13485 certification underscores Aprios’ ability to meet the strict regulatory requirements of the medical device industry. From process validation and risk management to traceability and record control, our systems are designed to maintain quality and compliance throughout every phase of development. Whether we’re producing surgical components or diagnostic housings, customers can have complete confidence in our controls and documentation.
FDA Registered Facility
Aprios is an FDA-registered manufacturing facility, qualified to produce components and assemblies for regulated medical devices. This registration confirms that our processes meet the standards required by the U.S. Food and Drug Administration for cleanliness, traceability, and process validation. It also reinforces our role as a trusted partner to OEMs navigating complex compliance landscapes.
ITAR Registered
Aprios is registered with the U.S. Department of State under the International Traffic in Arms Regulations (ITAR). This allows us to securely handle sensitive data, components, and assemblies for defense and aerospace applications. Our facilities and systems are structured to maintain strict confidentiality and control, ensuring all projects are executed in full compliance with export and security requirements.
UL Listed Manufacturing
Aprios manufactures components and assemblies that comply with Underwriters Laboratories (UL) standards for safety, performance, and reliability. Our UL listing demonstrates that materials and processes used in production meet the highest benchmarks for electrical, mechanical, and environmental safety—helping our customers meet certification goals faster and with confidence.
Let’s Talk Compliance and Quality
Connect with our team to see how Aprios’ certifications help reduce risk, simplify validation, and keep your program moving forward with confidence.
