Ampacet Europe Achieves ISO 13485 Certification, Strengthening Commitment to Medical-Grade Quality

ISO 13485 certification as a major milestone for Ampacet

This certification demonstrates Ampacet’s commitment to meeting the stringent regulatory and customer requirements associated with medical applications. ISO 13485 establishes a framework for consistent design, development, production and delivery of materials used in medical devices, ensuring safety, reliability and traceability throughout the supply chain.

“Achieving ISO 13485 certification is a significant milestone for Ampacet,” said Thomas van Hunsel, Ampacet Europe Strategic Business Manager Healthcare. “It reflects our dedication to supporting our customers in the healthcare sector with high-quality, compliant solutions and it reinforces our position as a trusted partner for medical-grade materials.”

Ampacet strengthens the supply of color and additive masterbatches for the healthcare industry

The certification covers Ampacet’s processes related to the manufacturing and supply of color and additive masterbatches intended for use in medical applications. By adhering to ISO 13485 standards, Ampacet enhances its ability to provide products that meet strict regulatory expectations while maintaining consistent quality and performance.

With growing demand for safe and reliable medical materials, Ampacet continues to invest in advanced quality systems, regulatory expertise and innovation to better serve the healthcare industry.