Accumold has achieved its ISO 13485 recertification, a globally recognised quality management standard for the medical device industry. This achievement reaffirms the precision micro moulding specialist’s commitment to meeting the stringent quality, safety, and regulatory demands of the medical sector.
Accumold
Accumold achieves ISO 13485 recertification
Receiving the ISO 13485 standard proves that Accumold consistently meets customer and regulatory requirements through a robust, risk-based quality management system. For its users, the recertification offers reassurance that the company has the systems, processes, and expertise to deliver ultra-precise, reliable micro moulded components for demanding medical applications.
“We work with the most exacting medical device companies in the world, and they rightly expect nothing less than absolute precision, traceability, and reliability,” said Roger Hargens, CEO of Accumold. “Our ISO 13485 recertification isn’t just a checkbox. It’s a reflection of how seriously we take our responsibility in the supply chain, and our commitment to patient safety and product performance.”
The medical industry is always pushing the boundaries in terms of miniaturisation. Accumold’s micro moulding expertise (backed by in-house tooling, cleanroom production, and advanced metrology) ensures that the company can meet these challenges.
Accumold’s vertically integrated model is what sets it apart. By controlling every stage of production within ISO 13485-certified systems, the company can optimise every process for performance, consistency, and compliance. This helps to reduce risks while also shortening development timelines and ensuring scalability.
“As the demand for micro-sized medical components grows, so does the need for supply chain partners that don’t just promise quality, but prove it,” concluded Hargens. “This recertification is a clear signal to our customers that we’re invested in maintaining the highest standards, today and into the future.”