CREATIVE SOLUTIONS TO PAVE THE PATH TO THE MEDICAL DEVICE MARKET
Our Expertise
Professional, Creative & Flexible Support
The medical device industry is a fast-growing yet challenging space.
Constantly evolving regulatory environment requires an expert partner, helping you identify the regulatory requirements as well as plan and conduct clinical studies for your medical device, anticipate risks and address issues before they arise.
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We are your partner from product concept to global marketing, deploying innovative strategy with on the ground insight, negotiate with FDA, CE Notified Bodies and other regulatory authorities. Asking the right questions and collaborate with your team to provide hands-on support and identify creative, yet compliant solutions for your challenges.
Expert Guidance & Submissions
With years of experience, we have the capabilities and expertise to take your business to the next level. We combine our insights and skills to create a cost - effective, risk based regulatory strategy to facilitate your company expansion into global markets. We’re proud to provide hands-on regulatory support through the product life cycle, from concept to post market stage, with specialization in FDA and CE regulations; resolving regulatory issues while communicating directly with FDA and other regulatory authorities.
Istvan Petak; Genomate Health
"Working with Dalia Givony has been a great experience. Her solid understanding of regulatory frameworks in both the EU and US has significantly advanced our regulatory strategy. Throughout our collaboration, Dalia consistently demonstrated professionalism and delivered her work in a timely manner, effectively navigating complex regulations. Her collaborative approach and clear communication style make her a reliable partner in any project. I highly recommend Dalia for regulatory projects."
Hagay Levyt; Iluria
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"Dalia is a super professional regulatory advisor. She assisted us in both our FDA and CE, UK processes and was instrumental in establishing our product strategy."
Ava Diamond; FertilAI
"We have the good fortune of working with Dalia as our regulatory consultant for an AI-based software medical device. Dalia's professionalism shines through in every interaction, from helping prepare the regulatory strategy to managing the submission process for both CE and FDA. Dalia is extremely professional, knowledgeable and dedicated. I cannot recommend her more; it has been a pleasure working with her"
Gadi Sicherman; Guide In Medical
​"Dalia is mission dedicated, creative and open minded consultant that leads you to the target with full responsibility and focused results.
Definitely excellent, exceptional and unique successful choice we made."
Miron Krokhmal; BactoByte
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"Dalia is a motivated, forward-thinking, and intelligent regulatory consultant who has lots of knowledge in her field. She understands complex issues even when outside of her direct area of expertise. For Dalia, the job is the most important thing to do. Dalia is dedicated, self-motivated, methodical, and very capable. Ambitious and independent expert. She denotes a lot of analytical capability and learns quickly, and I would no doubt working with Dalia once again in the future."
Michael Lemanski; Smart Lamp Ballast
"Dalia prepared for us the Regulatory Strategy for our new dry eye treatment device. During our cooperation Dalia demonstrated a high level of professionalism, fast response, willing to help, knowledge of FDA regulation and international standards. Anyone who needs regulatory consultation will be satisfied from the service Dalia provides.​".
