Certifications
We at Acme Monaco are committed to the concept of TOTAL QUALITY and CONTINUOUS IMPROVEMENT and make every effort to provide you, THE CUSTOMER, with QUALITY OF PRICE, QUALITY OF PRODUCT, and QUALITY OF DELIVERY.
MDR Certification
Medical Device Regulation
Establishes strict requirements for the design, manufacture, safety, and clinical evaluation of Orthodontic devices to ensure they meet EU Regulations.
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ISO 13485
International Organization for Standardization
Quality management system certification ensuring consistent quality in products and services in the medical device industry.
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ISO 9001
International Organization for Standardization
Quality management system certification ensuring consistent quality in products and services.
View PDF →Quality & Regulatory
Commitment to Quality and Compliance
At Acme Monaco Corporation, quality is the foundation of everything we manufacture. Our Quality Management System (QMS) is designed to ensure that every product meets the highest standards of safety, reliability, and regulatory compliance.
For over five decades, we have supported medical device manufacturers by delivering precision components produced under controlled, validated processes. Our systems emphasize risk-based thinking, traceability, and continuous improvement to ensure consistent product performance and regulatory confidence for our customers worldwide.
Quality Management System
Acme Monaco maintains a comprehensive Quality Management System that supports the design, manufacture, and distribution of medical device components.
Our quality system is built to meet global regulatory expectations and is structured to ensure that quality is integrated into every stage of product realization—from raw material sourcing through final inspection and shipment. Our quality culture emphasizes patient safety, prevention, data-driven decision making, and continuous improvement to ensure our customers receive reliable, compliant components.
Regulatory Compliance
Acme Monaco supports customers operating in regulated medical device markets around the world. Our systems and processes are aligned with recognized regulatory frameworks to ensure the consistent manufacture of compliant components.
Our regulatory framework includes:
- Quality Management System Certified to ISO 13485
- Compliance with the U.S. FDA medical device manufacturing requirements
- Support of manufacturers operating under EU Medical Device Regulation (MDR 2017/745)
- Established procedures for regulatory documentation and traceability
Manufacturing Quality Controls
Quality is integrated into our manufacturing processes through strict process control, inspection, and verification activities.
Process Controls
Manufacturing processes are developed and maintained using structured controls that ensure repeatability and consistency. Equipment and production processes are qualified and monitored to maintain stable production conditions.
Inspection and Testing
Products are verified throughout the manufacturing process using multiple layers of inspection and testing, including:
- Incoming material inspection
- In-process dimensional and visual inspection
- Final inspection prior to release
- Mechanical and performance testing where required