PrintAccumold, a global leader in precision micro molding, is proud to announce that it has achieved successful ISO 13485 recertifiction, a globally recognized quality management standard for the medical device industry. This milestone reaffirms Accumold’s longstanding commitment to meeting the stringent quality, safety, and regulatory demands of the medical sector.
ISO 13485 is more than a quality standard, it’s a benchmark of trust for medical device OEMs. It validates that Accumold consistently meets customer and regulatory requirements through a robust, risk-based quality management system. For customers, this recertification offers powerful reassurance that Accumold has the systems, processes, and expertise in place to deliver ultra-precise, reliable micro molded components for even the most 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,” says 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.”
From drug delivery devices and surgical tools to microfluidic components and implantables, the medical industry continues to push boundaries in miniaturization. Accumold’s micro molding expertise (backed by in-house tooling, cleanroom production, and advanced metrology) enables it to meet this challenge with confidence.
What sets Accumold apart is its vertically integrated model. By controlling every stage of production, from mold design to packaging, within ISO 13485-certified systems, the company can optimize every process for performance, consistency, and compliance. This level of control not only reduces risk but also shortens development timelines and ensures scalability from early-stage prototyping through to high-volume manufacturing.
“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,” adds Hargens. “This recertification is a clear signal to our customers that we’re invested in maintaining the highest standards, today and into the future.”