Achieving ISO 13485:2016 Certification: What It Means for DINGS' Motion USA and Our Customers
We are proud to announce that DINGS’ Motion has achieved ISO 13485:2016 certification, a globally recognized standard for quality management systems in medical device manufacturing. This certification is a testament to our ongoing commitment to precision, safety, and reliability, particularly for our customers in biomedical, life sciences, and laboratory automation industries.
What is ISO 13485:2016?
ISO 13485:2016 is an internationally recognized standard that outlines the quality management system (QMS) requirements for organizations involved in medical device manufacturing, design, production, and distribution. It is a crucial certification for companies supplying components for medical and life sciences applications, as it ensures compliance with strict regulatory and customer requirements.
Why This Certification Matters
For our customers, this certification represents more than just compliance—it is a guarantee of quality and reliability in every product we supply. Stepper linear actuators and motion control solutions are vital components in medical devices such as:
Automated Pipetting Systems
Ventilators and Respiratory Equipment
Medical Imaging Devices
Robotic Surgery Systems
Laboratory Diagnostic Equipment
ISO 13485:2016 certification means that every DINGS' Motion USA product, meets the highest standards for quality, safety, and risk management, making them suitable for use in critical medical and life science applications.
Key Criteria for ISO 13485:2016 Certification
To achieve this certification, our parent company underwent a rigorous auditing process, ensuring compliance with key quality and regulatory standards. These include:
1. Strict Quality Control Processes
ISO 13485:2016 requires comprehensive quality control measures throughout every stage of production, from design and material selection to final assembly and testing. This ensures that each component meets consistent and repeatable performance standards.
2. Risk Management & Regulatory Compliance
Medical device components must comply with strict risk management guidelines, ensuring that potential failures and hazards are identified and mitigated early in the design and manufacturing process.
3. Traceability & Documentation
Our quality management system ensures that all parts, materials, and processes are fully documented and traceable, which is critical for compliance with FDA and global regulatory requirements.
4. Continual Improvement & Customer Satisfaction
ISO 13485:2016 requires organizations to engage in continuous improvement efforts, ensuring that products and processes evolve to meet changing industry needs while maintaining customer satisfaction.
How This Benefits Our Customers
Reliability & Performance Assurance
ISO 13485:2016 certification means that our motion control solutions meet the highest standards, providing consistent, high-precision motion for critical applications.
Regulatory Compliance Simplified
For OEMs and medical device manufacturers, sourcing components from an ISO 13485:2016-certified supplier simplifies regulatory approvals and ensures compliance with global medical device standards.
Stronger Quality Partnerships
By choosing DINGS’ Motion USA, customers are partnering with a supplier that prioritizes quality, risk mitigation, and continuous improvement—essential qualities in the high-stakes medical and life sciences industries.
Final Thoughts: A Commitment to Excellence
Achieving ISO 13485:2016 certification is a significant milestone for DINGS’ Motion and reflects our dedication to delivering high-quality, precision-engineered motion control solutions. As we continue to grow and innovate, we remain committed to upholding the highest industry standards to serve our customers in medical, laboratory automation, and life sciences.
For more information on our certified motion control solutions, contact us today!