Steven Mayol, a lead consultant at MIS Fractional, is a subject matter expert in extrusion with over 25 years of experience in medical device and catheter applications, specializing in single and multi-lumen extrusions as well as co-extrusions. With a BS in Plastics Engineering from the University of Massachusetts Lowell, he brings a strong foundation to his work, excelling in guiding medical device manufacturers from design to production, developing robust processes, and implementing Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with industry procedures and guidelines. Steven also teaches and provides hands-on training through Systematic Extrusion (https://systematicextrusion.com/), sharing his expertise to empower professionals in the field. His consulting services include:

• Extrusion Expertise: Proficiency in extrusion processes for single-lumen, multi-lumen, and co-extruded designs, working with a wide range of materials for medical device applications.
• Alternative Material Selection: Expertise in selecting alternative materials to optimize performance, cost, and manufacturability in medical device applications.
• Equipment Solutions: Tooling design, machine integration, and knowledge of all extruders and downstream equipment to enhance manufacturing processes.
• Design to Production: Comprehensive support from product design through to production, ensuring manufacturability and efficiency.
• Process Development and Validation: Development of processes and execution of Test Method Validations (IQ, OQ, PQ, PPQ) to meet regulatory and procedural standards.
• Quality Management: Implementation of quality management practices to ensure compliance and product reliability throughout the manufacturing process.
• Certifications: Certified as Extrusion Master I™ and Extrusion Master II™ by Systematic Extrusion LLC, reflecting his advanced expertise in the field.