D&R Products is a privately-owned, US-based contract manufacturer of medical instruments and devices. Quality: ISO 13485:2003 Certified, ISO Class 7 Cleanroom, CE Compliant, FDA Registered, GMP Compliant In-process Inspection, Quality Documentation, Process Capability (Cpk), Risk Analysis (FMEA), Control plans, Process validation, Customer Flow maps, Customer-specific documentation protocols Engineering: Design for Manufacturability, Design of Experiments, SolidWorks, Inventor, AutoCAD Modeling/Drawing, Process Engineering, Fixture Design / Manufacturing, Tool Design/Manufacturing Primary Operations: CNC Machining, Milling, Turning (Swiss / American), Multi-Axis Grinding (Robotic), Centerless Grinding, Wire EDM Secondary Operations: Laser and Plasma Resistance Welding, Electropolish / Passivation, (10x) Mechanical Deburring, Knurling, Bead Blasting, Pressing / Coining , Tumbling, Buffing, Pressing, Coining, Heat Shrink Application, Induction Bonding Final Assembly: Lasermarking, Bending, Pressing, Ultrasonic Cleaning, Packaging: Tyvek Pouch / Blisterpack, Cleanroom Class 10,000 (ISO Class 7), Cleanroom Class 100,000 (ISO Class 8)