Rekky Technology has been certified to ISO 13485:2016, the international standard for quality management systems applied to medical device organizations. The certification covers the design and manufacture of platinum-cured silicone tubing and reinforced hose used in medical and pharmaceutical fluid transfer.

Strengthening the quality system

ISO 13485 emphasizes risk management, traceability and controlled processes throughout the product lifecycle. Combined with existing FDA, USP Class VI, ISO 10993, LFGB and REACH compliance, the certification further de-risks Rekky's supply to regulated industries.

Customers in biopharma and medical device manufacturing now receive additional documentation support, including batch-specific Certificates of Analysis and material conformance records.