Introduction
After several years working in the universe of medical devices, I decided to create Evalia and use my experience to serve medical device manufacturers. I have been working with various products, in ophthalmology, orthopedics (hip prostheses, knee prostheses, foot screws), ENT (cochlear implants), as well as associated surgical tools and software. Based in Bourgogne Franche-Comté (France), my missions extend internationally.
Let's work together !
Navigating the maze of regulatory requirements related to clinical evaluation and post-market clinical follow-up under the MDR (EU) 2017/745 and its amendements, directives MDD 93/42/EEC and AIMDD 90/385/EEC which are partly still applicable, and related guidelines (MEDDEV 2.7/1 Rev. 4, MDCGs) can be tricky.
And this is without considering specific requirements related to the documentation that lies at the regulatory and clinical affairs frontier, which only complicates the conformity assessment to the applicable general requirements.
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Thus, I offer medical device manufacturers to write their clinical evalutation documentation, and consult regarding their processes. I evaluate and update existing documentation, or create it from scratch depeding on the needs. Finally, I can also evaluate the clinical strategy​​​​​​​​ to improve coordination and planification..
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Whether you require an occasional or regular support, temporary or long-term, an extra pair of eyes or full-scale support, I get out of my comfort zone so you don't have to.
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Not each and every solicitations require a quote or an invoice, feel free to reach out if you have any question!
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My values
Self-disciplined and using a systematic and holistic approach,
I act thoughtfully and diligently.​
Challenges we face are constantly evolving, so does my skills.
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Dedicated, ethically and environmentally concerned, I offer my clients to financially support charitable, environmental or humanitarian organizations,
by redistributing a part of my earnings to these organizations​
