Product Focus: Test and Quality Control

Why It Matters

These technologies enable nondestructive inspection and real‑time process validation, reducing scrap and accelerating time‑to‑market for regulated medical products. The regulatory support service also lowers barriers for AI diagnostics to achieve CE marking, strengthening market entry.

Key Takeaways

• LK Metrology's CoreX 350 offers shop‑floor CT scanning without fixturing
• Micro‑Epsilon IMS5200‑TH provides sub‑nanometer, thermally‑stabilized measurements
• Kistler maXYmos integrates force, torque, pressure sensors for real‑time validation
• DNV’s IVDR program streamlines AI diagnostic compliance for European markets
• Combined solutions boost nondestructive testing, traceability, and regulatory readiness

Pulse Analysis

The medical‑device sector is increasingly reliant on nondestructive testing to verify internal geometry and material integrity without compromising product sterility. LK Metrology’s new CoreX 350 industrial CT system brings high‑resolution X‑ray imaging directly to the production floor, eliminating the need for costly fixtures or part disassembly. By generating precise volumetric data, manufacturers can perform GD&T assessments, porosity checks, and wall‑thickness mapping on molded, machined, and additively manufactured components, accelerating quality‑control cycles and reducing scrap rates.

Precision metrology and real‑time process monitoring are becoming cornerstones of compliant manufacturing. Micro‑Epsilon’s IMS5200‑TH interferometric sensor delivers sub‑nanometer displacement accuracy with built‑in thermal stabilization, making it ideal for semiconductor and medical‑device tool integration where drift can jeopardize yields. Complementing this, Kistler’s maXYmos platform aggregates force, torque, pressure and displacement data, providing instant curve evaluation and closed‑loop automation. The combined sensor suite ensures each assembly step meets defined tolerances, supports traceability, and satisfies stringent regulatory documentation requirements.

Regulatory scrutiny is intensifying, especially for AI‑driven in‑vitro diagnostics under the European IVDR framework. DNV’s new certification support program offers structured conformity assessments, technical‑document reviews, and software‑lifecycle validation tailored to algorithmic diagnostic tools. By streamlining the path to CE marking, the service reduces time‑to‑market and mitigates compliance risk for innovators targeting the EU market. Together, these inspection, metrology, and certification solutions create a cohesive ecosystem that enhances product quality, accelerates development, and aligns with evolving global regulatory standards.