GLOBAL REGULATORY & CLINICAL STRATEGY FOR AI SaMD
We believe successful regulatory strategy begins with understanding the technology behind the product. Clients choose Dalia Givony Regulatory & Clinical Consulting for our ability to combine technical insight, clinical understanding and global regulatory expertise into practical, business-oriented strategies.
With executive regulatory leadership experience at Medtronic, over 20 years in the medical device industry, and extensive expertise in AI Software as a Medical Device (AI SaMD), digital health, medical devices and IVDs, we help companies confidently navigate complex regulatory challenges and accelerate successful global market access.
Working closely with development, clinical, quality and executive teams to build practical regulatory and clinical strategies.
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
"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
"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.".
Trusted by startups, scale-ups and established medical device manufacturers developing innovative technologies for global markets.
