Opale DM Email Formats
Business Consulting and Services • 
Saint-Mandé, Île-de-France, France • 1-10 Employees
Key Contact at Opale DM
Mathilde Beal
Owner
Company overview
| Headquarters | Saint-Mandé, Île-de-France, France |
| NAICS | 5416 |
| Keywords | Supplier Management, Design Validation, Medical Devices, Contract Manufacturing, Usability, FDA, Digital Health, Iso 13485, Iso 14971, Medical Software, Process Validation, Iec 62304, Iec 62366, 510K, Iec 60601-1, TGA, Design Verification, Risks Analysis, Design Transfer, Clinical Evaluation Report, Purchase Control, 2017/745, Iec 60601-1-2 (Emc), Technical Compliance |
| Founded | 2019 |
| Employees | 1-10 |
About 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.
Employees by Management Level
Total employees: 1-10
Seniority
Employees
Funding Data
Opale DM has never raised funding before.
Netherlands
United Kingdom
United States
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