Opale DM

Consulting services for all the stages of the medical device product development lifecycle. My professional previous experiences are both about the technical and regulatory aspects of a successful medical device launch. My core skills concerns Verification and Validation, usability and clinical validation, industrialisation, commissioning, services and maintenance, CE and 510k technical File preparation, Sustaining and Design change, Compliance Remediation projects. I am passionate about technology with a background in mechanical/mechatronics engineering and Industrial Management. I held R&D positions for pulse oximeter, surgical light, VNI ventilator manufacturers (active medical devices) and for intestinal stents, surgical and dental instruments manufacturers (passive biocompatible or implantable medical device). Feel you free to contact me to discuss of your project. I would be happy to guide you in the technico-regulatory mountain.