Mélanie Roulet, founder of DM-STRAT
I spent twenty years working for medical device manufacturers, first as a quality engineer, then as quality and regulatory director. In April 2022, I founded DM-STRAT to put that experience at the service of other companies in the sector.
My career has spanned very different devices, from wound dressings and care kits to implantable vascular prostheses. It is this hands-on experience across the entire risk scale that I bring to every engagement.
Professional background
Twenty years in industry before DM-STRAT, from quality engineering to quality and regulatory management, on devices from Class I to Class III.
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Cardial a BARD subsidiary
Process and systems quality engineer, then quality and regulatory affairs manager
Class III devices: vascular prostheses and surgical glue.
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GIBAUD Össur group
Quality director
Class I medical devices.
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Tetra Médical medical device manufacturer
Quality and regulatory director
Care kits, wound dressings and surgical drapes, from Class I to Class IIa.
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DM-STRAT founder
Quality and regulatory affairs consultant
Supporting manufacturers, distributors, importers and MedTech start-ups. I lead assignments myself and bring in complementary experts when a project requires it.
Continuing education
Standards and regulations evolve: I train regularly so that my work reflects current requirements.
ISO 13485:2016 Lead Auditor
BSI
Recent training includes
- Technical documentationMDR Technical Documentation
- Risk managementISO 14971
- Biological evaluationISO 10993-1
- Sterilisationgamma irradiation, ethylene oxide
- Clinical evaluation
- Initial education
- Engineering degree in textile materials, ITECH Lyon (1998–2001)
- Languages
- Professional English
DM-STRAT
Founded in April 2022, DM-STRAT is the company through which I provide quality and regulatory affairs consulting for medical devices.
I personally lead every engagement. When a project requires it, I bring in complementary experts and remain your point of contact.