By Nel PreTech
Meet regulatory requirements and improve quality on critical parts. Medical devices can have critical dimensions, tight tolerances, and complex geometries. With advanced technologies, the experts at Nel PreTech can provide the inspection reports and data you need for compliance. Keep up with regulatory requirements and changes with our accredited quality management system With an A2LA scope and certificate you can have confidence in our: - Procedures and policies - Quality of environment - Measurement uncertainty analysis - Calibration standards - Traceability Get dimensional inspections on specific ISO standards Medical device manufacturers in the United States must obtain specific ISO certifications before marketing their products worldwide. These standards are crucial in establishing credibility with customers and demonstrating that the devices meet international quality, risk management, and safety requirements. Meeting these ISO standards provides tangible benefits for both manufacturers and customers. Let us help you save time, money, and effort with medical device dimensional inspection. A few examples of the ISO inspection requirements we can help you with: - ISO 27186: Four-pole connector system for active implantable medical devices - ISO 80369: Small-bore connectors for liquids and gases - ISO 9626: Rigid stainless steel tubing - ISO 18250: Reservoir delivery systems in enteral applications - ISO 7864: Single-use hypodermic needles Improve engineering design and manufacturing functions with accurate and timely data Get accurate, reliable, and timely results that will help you make informed decisions about your designs and stay ahead of your competition. Verify accuracy and integrity of parts With extremely accurate measurements down to the micron level you get precise geometries, better quality control, and thorough failure analysis on your critical medical components. Data from scans can be compared to the CAD model, other parts, or other datasets Creating overlay comparisons can quickly help a manufacturer determine which process turns out parts closest to the intended design. Common Medical Device Services: - Flaw detection - Assembly accuracy - Metrology - Failure analysis - Wall thickness analysis - Reverse engineering - Detect & modify deviations - Colormaps - Part-to-part compare - Part-to-CAD compare - Define porosity & inclusions - Conduct FEA on real-world parts - Leak path interrogation Additional Benefits Speed up product development with our turn-key, 3d scanning and engineering solutions. Integrate new technology and services into your existing workflows for faster decision making Simultaneous access for your entire team: Inspection reports and datasets at your fingertips Mitigate problems that lead to recalls
