ThermoFab Achieves ISO 13485:2016 Certification - Elevating Quality and Precision in Manufacturing
By achieving this certification, ThermoFab demonstrates its commitment to excellence in quality management, with a comprehensive system that encompasses all facets of design, development, production, and customer service in the manufacture of medical devices.
ThermoFab, a trusted leader in precision thermoforming and injection molding, proudly announces its achievement of ISO 13485:2016 certification, an international benchmark for quality management systems in the medical device industry. By achieving this certification, ThermoFab demonstrates its commitment to excellence in quality management, with a comprehensive system that encompasses all facets of design, development, production, and customer service in the manufacture of medical devices.
The attainment of ISO 13485:2016 certification positions ThermoFab to better serve its customers by adhering to stringent regulatory requirements and demonstrating a commitment to continuous improvement. This not only optimizes current production but also positions ThermoFab to expand its market reach, appealing to new customers seeking certified manufacturing partners.
Enhanced Quality Measures and Team Expansion
The quality team, led by Mellisa Wright, a seasoned expert with extensive experience in quality assurance, has been instrumental in driving these initiatives. Mellisa, transitioning from a role in thermoforming to Quality Lead, has brought invaluable insights into ThermoFab's quality control processes and instituted new measures and procedures to foster a culture of quality awareness throughout the organization.
Supporting her in these efforts are Arti Jivanani and Nicole Rodriguez, both dedicated Quality Inspectors, who have contributed significantly to refining ThermoFab's quality inspection processes. This skilled team has been instrumental in transitioning from visual-only inspections to precise measurement-based checks for every component, thereby increasing the reliability and precision of ThermoFab's products.
Driving Excellence through New Technology
With ISO 13485:2016 certification, ThermoFab is well-positioned to continue enhancing its quality processes and expand into new markets. The integration of new technology, the Keyence WM6210, will enable more detailed analysis of components, further improving measurement accuracy and helping reduce defects. Additionally, ThermoFab's strengthened documentation practices ensure that all processes are traceable and compliant with medical industry standards.
About ThermoFab
At ThermoFab, our comprehensive suite of thermoforming and injection molding services, focuses on key markets including surgical robotics, organ transport devices, genetic sequencing devices, and people scanning technologies. With a wealth of experience in managing large, multi-part projects, our capabilities encompass the entire production lifecycle, from initial prototyping to full-scale production and assembly-with our dedicated team working closely with you to bring your concepts to life.
Featured Product
FLIR Si1-LD - Industrial Acoustic Imaging Camera for Compressed Air Leak Detection
The FLIR Si1-LD is an easy-to-use acoustic imaging camera for locating and quantifying pressurized leaks in compressed air systems. This lightweight, one-handed camera is designed to help maintenance, manufacturing, and engineering professionals identify air leaks faster than with traditional methods. Built with a carefully constructed array of MEMS microphones for high sensitivity, the Si1-LD produces a precise acoustic image that visually displays ultrasonic information, even in loud, industrial environments. The acoustic image is overlaid in real time on a digital image, allowing you to accurately pinpoint the source of the sound, with onboard analytics which quantify the losses being incurred. The Si1-LD features a plugin that enables you to import acoustic images to FLIR Thermal Studio suite for offline editing, analysis, and advanced report creation. Field analysis and reporting can also be done using the FLIR Acoustic Camera Viewer cloud service. Transferring of images can be managed via memory stick or USB data cable. Through a regular maintenance routine, the FLIR Si1-LD can help facilities reduce their environmental impact and save money on utility bills.
