Ampacet, a specialist in masterbatch solutions, has announced the achievement of ISO 13485 certification, a benchmark for quality management systems in the medical device sector.
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.”
The certification covers Ampacet’s processes related to the manufacturing and supply of colour 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.