FOREACH Achieves ISO 13485 Medical Device Quality Management System Certification
ISO 13485 certification strengthens process control, documentation, traceability, and continual improvement for medical device, IVD, and life science customer projects.
Strengthening Medical Device Quality Management
ISO 13485 specifies quality management requirements for medical devices and related services. The certification strengthens FOREACH processes for risk awareness, documentation, process control, quality records, and continual improvement.
Supporting IVD and Life Science Projects
Microfluidic pumps, valves, sensors, probes, fittings, and tubing assemblies are used in IVD, life science, and laboratory equipment. A structured quality system supports supplier audits, project introduction, batch management, and traceability.
Improved Process Control and Traceability
Product requirements, design validation, supplier management, manufacturing, inspection release, and nonconformance handling are managed through documented quality processes.
Quality System Certification
ISO 13485 certification applies to the quality management system. It does not mean that every FOREACH product has received separate medical device registration or individual product certification.