Leading Your Company to Achieve Successful Device Development Milestones
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With MedTech SMEs, you can rely on our advisors to plan and execute an effective strategy for your device development milestones from R&D through clinical and regulatory requirements to the market.
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Our comprehensive understanding of the development process and its liabilities improves your pre-clinical and clinical strategies to achieve high-quality regulatory submission packages and faster market clearance and access.
ABOUT
MedTech SMEs is a clinical and regulatory affairs consultancy founded by Dr. Danielle Nusimovici-Avadis, with over 22 years of experience in the medical device field.
MedTech SMEs’ team is an eclectic international group of professional MD and PhD subject matter experts experienced in both the clinical and regulatory fields, founding the advantage of making device development a seamless process.
MedTech SMEs partner with both start-up and large medical device companies to establish their clinical data and application strategies as well as achieve regulatory milestones for legacy and new technologies.
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MedTech SMEs supports companies with a complete strategic point of view from design to market with the understanding of the quality, clinical, and regulatory requirements of competent authorities.
Dr. Danielle Nusimovici-Avadis
CEO & Founder
Danielle is a subject matter expert in diverse clinical fields and worldwide regulatory affairs.
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She is an experienced medical reviewer on behalf of European notified bodies, clinical auditor, and auditor for venture capital and due diligence audits.
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Danielle has years of hands-on experience in the medical device industry, combined with the business acumen of an executive.
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She has a unique understanding of worldwide regulatory requirements, clinical fields, users, and medical devices, providing practical input to R&D departments and companies.
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Her experience has allowed her to gain a valuable understanding of the industry with creative input into clinical, regulatory, and business strategy.
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We Are Partners,
Not Just Consultants
SERVICES
Architecting Your Medical Device
MedTech SMEs builds your device development process brick by brick while visioning how your final product enters the market.
We can incorporate our team expertise at any stage of
your device development process.
One of a Kind Creative & Practical Consulting Services
Human sized company with strong internal communications and experience sharing
Subject matter experts in taking new products from R&D to the medical market
Hands-on and practical approach with an understanding of the regulatory requirements and realistic possibilities
Linking between the R&D, clinical, and regulatory departments
Architecting device documents and development processes to achieve fast approval
Building and presenting a consistent story line of the submitted data
Well connected and experienced in Israel and worldwide
OUR HAPPY CLIENTS
TESTIMONIALS
