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.
Company Details
- Employees
- 1
- Founded
- -
- Address
- 94160, Saint Mandé,france
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- Medical Devices, IEC 60601-1, IEC 62304, IEC 62366, TGA, FDA, 510k, Design Transfer, Digital Health, 2017/745, IEC 60601-1-2 (EMC), Supplier Management, Contract Manufacturing, Purchase Control, technical Compliance, Risks Analysis, ISO 14971, ISO 13485, Clinical Evaluation Report, Process Validation, Medical Software, Design Verification, Design Validation, Usability.
- HQ
- Saint Mandé
Opale Dm Questions
Opale Dm's LinkedIn profile is https://fr.linkedin.com/company/opale-dm
Opale Dm has
1 employees.
View email and phone details for 1
employees at Opale Dm.
Opale Dm's industry is
Business Consulting and Services
Opale Dm's categories are Business Consulting and Services
Opale Dm's founding year is 2019
