cph-tech ApS

• Tech management services & Industrial consultancy, primarily within Life Science Project Management, Product Development, Supplier & Operations Management, Ramp up.R&D, NPI, cGMP, DfM, design transfer, DQ, FAT, SAT, IQ/OQ, PQ • Robust design methods, including DfM framework and requirement management • Strong interpersonal skills derived and developed by hands-on work with 30+ projects in R&D, manufacturing operations, production technology and supplier development. • Supply chain design, ramp up and run-in of new products, supporting and co-developing manufacturing processes with sub-suppliers, Commissioning of assembly/automation lines • Medical product design in accordance with ISO 13485, FDA 510(k), IEC 61610-1, GMP • Innovative, patent granted for thesis work and in development projects across industries • Geometric Product Specifications (GPS) drawings, 3D-Creo/SolidWorks • Injection molding and molding tool designs • Manufacturing processes development (e.g. rapid prototyping technologies, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding) associated with a medical device or biological application, including the documentation related to FAT, SAT, IQ, DOE & characterization, OQ, PQ, process FMEA, Gage R&R, Cpk process capability, SPC.

• Employees 1
• Founded 2022