April 7, 2026 11:50

Masterbatch manufacturer Ampacet has obtained ISO 13485 certification, the international standard for quality management systems specific to the medical device. The certification covers processes related to the production and supply of colour and additive masterbatches intended for this market.

The international standard sets out a framework for the formulation, development, production and delivery of materials used in medical devices, with the aim of ensuring safety, reliability and traceability throughout the supply chain.

“This is a significant milestone,” says Thomas van Hunsel, Strategic Business Manager Healthcare at Ampacet Europe, “which reflects our dedication to supporting our healthcare customers with high-quality solutions and strengthens our position as a trusted partner for medical materials.”

Headquartered in Tarrytown, New York, Ampacet employs more than 2,000 people across 21 manufacturing sites, as well as technical centres and colour development facilities, in 17 countries across the Americas, Asia and Europe.

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