ThermoFab Achieves ISO 13485:2016 Certification
ThermoFab Achieves ISO 13485:2016 Certification – Elevating Quality in the Manufacturing of Medical Device Plastic Enclosures
ThermoFab, a trusted leader in thermoforming and injection molding heavy gauge plastic enclosures, 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 Melissa Wright, a seasoned expert with extensive experience in quality assurance, has been instrumental in driving these initiatives. Melissa, 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
ThermoFab, offers a comprehensive suite of thermoforming and injection molding services for the manufacture of heavy gauge plastic enclosures for the medical and other critical highly regulated industries. Applications include surgical robotics, organ transport devices, genetic sequencing devices, people scanning technologies and more. With a wealth of experience in managing large, multi-part projects, our capabilities encompass the entire production lifecycle, from design and initial prototyping to full-scale production and assembly—with our dedicated team working closely with you to bring your concepts to life.
