Freelancer profile translated to English.
Back to original languageAbout Daniel
Support and co-construction of a quality management system according to ISO 13485 adapted to your company.
Preparation of regulatory technical documentation for CE marking, 510(k), DeNovo, PMA, Q-Sub for medical devices from class I to class III
Definition of regulatory strategies
Training on standards ISO 13485/ISO 14971/IEC 62304/IEC 82304-1
Internal audits according to ISO 19011
Normative Expertise
ISO 13485
IEC 62304
IEC 82304-1
ISO 62366-1
ISO 14971
IEC 81001-5-1
ISO 20417
Regulatory Expertise
Reg. 2017/745
Reg. 2017/746
21 CFR 820 - Quality system regulation
21 CFR 11 - Electronic records and electronic signature related
21 CFR 830 - UDI
21 CFR 801 - labeling
21 CFR 803 - Medical device reporting
21 CFR 806 - Medical devices reports
French
Native or bilingual
Remote only
Primarily works remotely
Experience
- EIRLMedical Device ConsultantDecember 2016 - Today (9 years and 6 months)Grenoble, FranceQuality and regulatory support for medical device development projects.
- PRAXIM medivisionCustomer Service Manager (PRAXIM) / Field Service Director (OMNILIFE Science)January 2014 - December 2016 (2 years and 11 months)Boston, MA, USAOMNI Life Science Transfer of customer service activities from PRAXIM to OMNI. Processes approved by the FDA during the first audit Implementation of stock policy, hotline service, consignment stocks, maintenance contracts. Guarantee of the PRAXIM customer request resolution process Optimization of customer service processes and guarantee of customer service process application according to ISO13485 Increase in profitability of maintenance contracts and customer service Monitoring of product performance in post-market surveillance studies.
- VI TECHNOLOGYCorporate Application EngineerApril 2006 - January 2014 (7 years and 9 months) Coordination and support of international sales and distribution teams. Technical support (phone/email), training, services, and advice. Commissioning of equipment at customer sites. Development of customer relationships, technical seminars, site visits, trade shows. Listening to and synthesizing customer needs and participation in new product development.
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Education
- DESS (Master 2) Optics and Photonics, Laser and Optics EngineeringUniversité Joseph Fourier (Grenoble I)2004DESS (Master 2) Optique et Photonique, Ingénierie laser et optique