Standards that Support
Long-term Reliability
Our Quality & Regulatory Affairs
A Quality System Built Into Every Stage
Mego Afek operates under a rigorous quality management system designed to ensure product safety, consistency, and reliability across all stages of development, manufacturing, and distribution.
All Mego Afek products are manufactured in compliance with ISO 13485:2016, supporting controlled processes and high standards for medical and aesthetic pneumatic compression therapy solutions.
Mego Afek works in accordance with international regulatory requirements, and its products hold key approvals and clearances, including U.S. FDA clearance, CE Mark, MHLW (Japan), and INMETRO approvals, subject to product type and regional regulations.
By embedding quality assurance and regulatory oversight into every aspect of operations, Mego Afek ensures that its compression therapy systems meet global standards and are trusted by healthcare professionals, partners, and patients worldwide.
From Raw Materials to Final Testing
Quality control begins with incoming raw materials, continues through every step of manufacturing and assembly, and ends with final testing of every device and garment before it leaves our facility. Because design, production and testing take place under one roof, our quality and engineering teams keep direct oversight of each product throughout its lifecycle.
Certifications and Approvals
- ISO 13485:2016 certified quality management system
- U.S. FDA clearance
- CE Mark
- MHLW approval (Japan)
- INMETRO approval
Approvals vary by product type and region.