R.S NESS Group - Solutions For Life Science Companies

This month’s R.S NESS Group - Solutions For Life Science Companies software validation training bu Yael Nuss at the microbiology diagnostics company hylabs (Hy Laboratories Ltd) was a great success! 🌟 We talked about how to check that the software fits its intended use and explored some core topics, such as: 👩💻The validation lifecycle 👨💻Risk management 👩💻Regulatory requirements The most exciting part? Seeing how engaged Hylabs participants were during the hands-on exercises! 🚀 It’s super rewarding to see professionals leave the training session with a clear understanding of the software validation principles that will help them continue to build tools for detecting and identifying microorganisms spreading infectious diseases! Would you like to stay up-to-date with the latest AI tools and their implementation in AI software validation? Sign up for our next workshop (link in comments)! #microbiology #healthtech #SoftwareValidation #training Yael Nuss Kevin Greenstein Rafi Shavit Rafi Montias Zohar Zehavi Nino Mamistvalov

Congratulations to our valued customers Nanox Vision (Nasdaq: NNOX) for receiving FDA clearance for the general use of Nanox.ARC!   We at R.S NESS Group - Solutions For Life Science Companies are honored to be working with you and managing the clinical trials. We’re very excited to see Nanox.ARC reach the market now that you’ve received the 510(k) for your digital multi-source 3D tomosynthesis imaging system. Can’t wait to see what 2025 has in store for Nanox! #Congratulations #NanoxVision #FDAApproval #MedicalImaging #DigitalHealth #InnovationInHealthcare #NanoxARC #Tomosynthesis #ClinicalTrials #CRO Cheli Gonnen Gabriel (Gabi) Salmon Rafi Shavit Rafi Montias Zohar Zehavi Nino Mamistvalov

Happy holidays to all our clients, partners, family, friends, and everyone in the life sciences community! Wishing you a winter filled with light and a year filled with: 🌈Audits passed with flying colors  👩🔬Successful clinical trials  ☑️As many regulatory approvals as you set out to get Here’s to a healthy, productive, and peaceful year ahead! Best wishes from all of us at R.S NESS Group - Solutions For Life Science Companies Rafi Shavit Zohar Zehavi Rafi Montias Gabriel (Gabi) Salmon Kevin Greenstein Nino Mamistvalov #HappyHolidays

𝐂𝐨𝐧𝐠𝐫𝐚𝐭𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐭𝐨 𝐚𝐥𝐥 𝐨𝐮𝐫 𝐜𝐮𝐬𝐭𝐨𝐦𝐞𝐫𝐬 𝐰𝐡𝐨 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞𝐝 𝐭𝐡𝐞𝐢𝐫 𝐢𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐚𝐮𝐝𝐢𝐭𝐬 𝐢𝐧 𝟐𝟎𝟐𝟒! 👏👏👏 We love ensuring companies are at their best when addressing such a wide range of #health issues, whether they’re helping patients with #sleep_apnea, building software solutions like AI-powered #ultrasound analysis, or providing treatment like #MedicalCannabis. And what does that look like from our customers’ perspective? Here’s one example, from DiA Imaging Analysis - acquired by Philips. “𝑅𝑆 𝑁𝐸𝑆𝑆 ℎ𝑎𝑠 𝑐𝑜𝑛𝑠𝑖𝑠𝑡𝑒𝑛𝑡𝑙𝑦 𝑑𝑒𝑚𝑜𝑛𝑠𝑡𝑟𝑎𝑡𝑒𝑑 𝑎 ℎ𝑖𝑔ℎ 𝑙𝑒𝑣𝑒𝑙 𝑜𝑓 𝑝𝑟𝑜𝑓𝑒𝑠𝑠𝑖𝑜𝑛𝑎𝑙𝑖𝑠𝑚, 𝑡𝑒𝑐ℎ𝑛𝑖𝑐𝑎𝑙 𝑒𝑥𝑝𝑒𝑟𝑡𝑖𝑠𝑒, 𝑎𝑛𝑑 𝑑𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑡𝑜 𝑒𝑛𝑠𝑢𝑟𝑒 𝑡ℎ𝑒 ℎ𝑖𝑔ℎ𝑒𝑠𝑡 𝑠𝑡𝑎𝑛𝑑𝑎𝑟𝑑𝑠 𝑜𝑓 𝑞𝑢𝑎𝑙𝑖𝑡𝑦 𝑎𝑛𝑑 𝑐𝑜𝑚𝑝𝑙𝑖𝑎𝑛𝑐𝑒 𝑎𝑟𝑒 𝑚𝑒𝑡.”  Thanks Michal Yaacobi, CTO and Co-Founder at DiA! We appreciate you too! 🤩 Here’s to helping even more amazing companies meet the highest standards of quality and #compliance in 2025! 🥂 #medicaldevice #medtech #audit Gabriel (Gabi) Salmon Rafi Montias Rafi Shavit Zohar Zehavi Nino Mamistvalov

It was fantastic seeing a full house at the R.S NESS Group offices in Netanya yesterday to hear from captivating and informative experts speak about how to go from a life sciences idea to a product on the market, and to meet founders and execs in the medtech space! Here’s a glimpse of what we discussed at the meetup: ▶️ Shlomo Mena, a strategic consultant who helps medtech startups navigate going to market, told founders to share their story when building relationships with investors and partners, and talk about what they want to change and not just which features the product will have ▶️Dr. Shai Melcer‏, head of the National Bio-convergence Program at the Israel Innovation Authority רשות החדשנות, spoke about new opportunities in the bioconvergence field and what Israeli startups can do to access those opportunities. ▶️Dr. Noam Keidar‏ spoke about his journey as co-founder of Dux Healthcare, a digital health startup using AI to predict epileptic seizures, and shared the lessons he’s learned along the way. ▶️ Liat Aharon Pollak, regulatory affairs director at R.S NESS Group - Solutions For Life Science Companies Group, said startups should plan their regulatory strategy at the outset and align their product roadmap with the safest, shortest and most compatible path to market. It was great hosting such engaging speakers! Many thanks to all who joined us, we look forward to seeing you at the next event! ‏Rafi Shavit‏ ‏Zohar Zehavi‏ ‏Rafi Montias‏ ‏Kevin Greenstein‏Gabriel (Gabi) Salmon) Nino Mamistvalov‏ ‏Olga Rosenman‏ ‏Estee Rosen אסטי רוזן‏ ‏ Gadi Klarsfeld‏ ‏Nikolai Kunicher‏ ‏Yochai Avrahami‏ ‏Dikla Shpangental‏ ‏Guy Attar‏ ‏Shalva Rocketlishvili‏Iris Fogel‏ ‏Michael Kardosh MBA MSc 🎗️ ∴ Neta Dahan Hason‏ #MeetUp #MedTech #LifeSciences #Innovation #BioConvergence #HealthcareStartups #DigitalHealth #RegulatoryStrategy #StartupJourney #MedTechFounders #Biotech #IsraelInnovation #Entrepreneurship #HealthcareInnovation

#MeetTheExpert #StartUpFounder #DigitalHealth Having a great idea that can improve people’s health is fantastic, but it’s only the first step toward having a marketable product. Dr. Noam Keidar will provide a behind-the-scenes view of how to go from idea to product, sharing his path to co-founder and CTO at Dux Healthcare, a digital health startup using AI to predict epileptic seizures. Some of his milestones along the way: ⭐ MD + PhD in biomedical engineering ⭐ AI research at an algorithmic trading company ⭐ Postdoctoral fellowship in computer science ⭐ Developing an AI-powered ECG interpretation app deployed at health centers worldwide ⭐ Founding Dux Healthcare to develop real-time personalized medicine We’re excited to hear Dr. Keidar’s insider perspective TOMORROW (Monday, Dec. 16) at a meetup for entrepreneurs and executives in life science technologies at R.S NESS Group - Solutions For Life Science Companies offices. Dr. Keidar will be joined by experts like Dr. Shai Melcer (who will speak about the National Bio-Convergence Program), Shlomo Mena (who will speak about how to approach strategic partners), and Dr. Liat Aharon Pollak (who will speak about early regulatory strategy in medical device development). Space is limited. Follow the link in the comments to reserve your spot. #InnovationInHealth #DigitalHealth #AIinHealthcare #EpilepsyAwareness #BiomedicalEngineering #StartupJourney #PersonalizedMedicine #EntrepreneurshipInHealthcare #LifeSciencesLeadership #RegulatoryStrategy #HealthTechInnovation

As 2024 comes to a close, are you on track with this year’s audit findings? Have you built an audit plan for 2025? If not, here’s a checklist to help make sure you’re ready for the new year: ✅ 𝐑𝐞𝐯𝐢𝐞𝐰 𝐲𝐨𝐮𝐫 𝟐𝟎𝟐𝟒 𝐚𝐮𝐝𝐢𝐭 𝐟𝐢𝐧𝐝𝐢𝐧𝐠𝐬.  Any open action items remaining from 2024? The first step is making sure you’re clear on what they are and understanding what you need to do about it ✅ 𝐓𝐚𝐤𝐞 𝐚𝐜𝐭𝐢𝐨𝐧 𝐨𝐧 𝐚𝐧𝐲 𝐨𝐩𝐞𝐧 𝐢𝐭𝐞𝐦𝐬 𝐲𝐨𝐮’𝐫𝐞 𝐫𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐥𝐞 𝐟𝐨𝐫. Is it a quick fix? Now’s your chance to resolve any remaining open items you can close by the end of the year. If the issue requires a longer-term fix, make sure you’ve asked QA for an extension and you can present a plan to resolve it within the approved timeframe. ✅ 𝐒𝐜𝐡𝐞𝐝𝐮𝐥𝐞 𝐲𝐨𝐮𝐫 𝟐𝟎𝟐𝟓 𝐢𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐚𝐮𝐝𝐢𝐭 𝐚𝐧𝐝 𝐲𝐨𝐮𝐫 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐫𝐞𝐯𝐢𝐞𝐰. Whether your audits take place in the beginning of the year or at the end, it’s best to make sure you’ve got them on the calendar. ✅ 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐰𝐡𝐞𝐭𝐡𝐞𝐫 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐧𝐞𝐞𝐝 𝐚𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐚𝐮𝐝𝐢𝐭𝐬 𝐨𝐫 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧𝐬 𝐢𝐧 𝟐𝟎𝟐𝟓. For instance, will you need a clinical evaluation in the coming year? Will you need post-market surveillance (PMS)? If so, now’s the time to schedule them. Reach out to R.S NESS Group - Solutions For Life Science Companies for some expert advice and to schedule your next audit. Gabriel (Gabi) Salmon Rafi Shavit Zohar Zehavi Rafi Montias

#MeetTheExpert #BioConvergence It’s a field that may shape the global future, in health care, climate, defense and more… …Bioconvergence. 👉 It’s the place where biology meets engineering. 👉 It’s been touted as Israel’s next growth engine. 👉 It’s the field that Dr. Shai Melcer, who heads the National Bio-convergence Program at the Israel Innovation Authority רשות החדשנות, will be sharing his insights on at R.S NESS offices on Monday, Dec. 16. We’re honored to be hosting Dr. Melcer, who also co-founded GRAM Biotech Venture Foundry and BioGiv, and served as CBO of Minovia Therapeutics, CEO of BIOHOUSE and executive director of the Jerusalem Development Authority’s BioJerusalem initiative. At our Dec. 16 meetup, entrepreneurs and executives in life science technologies will be meeting experts like Dr. Melcer, Shlomo Mena (who will speak about how to approach strategic partners), and Liat Aharon Pollak (who will speak about early regulator strategy in medical device development) – and get an inside view from co-founder and CTO Dr. Noam Keidar showcasing Dux Healthcare’s journey from idea to product. Don't miss out on this unique opportunity. Places are running out. Follow the link in the comments to reserve your spot.

💡 Inspire. Learn. Network. Succeed. #HealthTech Enterpreneurs - you are invited! Join us for an exclusive session illuminating the path from groundbreaking ideas to market-leading products. Event Highlights ✅ Shlomo Mena: Mastering Strategic Partnerships Learn from industry leaders about how to connect with and leverage strategic partners to accelerate your growth. ✅ Shai Melcer: Bio-Convergence in Focus Explore Israel's cutting-edge tech ecosystem and discover the national programs fueling innovation. ✅ Noam Keidar: Navigating the Early Startup Journey Dive into the unique challenges MedTech startups face and learn from a compelling case study. ✅ Liat Aharon Pollak: Why Early Regulatory Strategy Matters Uncover the pivotal role of regulatory planning in ensuring smooth product development and market entry. This isn’t just an event—it’s an opportunity to gain actionable insights, forge meaningful connections, and unlock the potential of your MedTech venture. 💡 Inspire. Learn. Network. Succeed. Spots are limited, so reserve your place now and be part of this transformative experience: https://lnkd.in/d7TKw4a5 Rafi Shavit Zohar Zehavi Rafi Montias Gabriel (Gabi) Salmon Kevin Greenstein

#MeetTheExpert Large multinationals are sought-after partners for many #healthtech companies looking for strategic collaboration or an exit, but it can be tough to figure out the best way to get their attention. Unless, of course, you have decades of experience working with multinationals! 👀 Shlomo Mena is the former general manager of Novartis Israel and former chairman of Pharma Israel, the association representing R&D-based pharmaceutical multinationals. He has a long track record of innovation, and now serves as a strategic consultant and board member to biotech and pharmaceutical companies and helps medtech startups navigate going to market. On Dec. 16, he’ll be speaking at the R.S NESS Group - Solutions For Life Science Companies headquarters in Netanya about building relationships with strategic partners. He’ll be addressing questions like: ➡️ When and how should a #medtech startup approach strategic pharmaceutical partners? ➡️ When is it the right time to start marketing your #pharma product? ➡️ How does your #biomedical idea bring added value to existing pharmaceutical solutions? 👉 Join #healthtech entrepreneurs and executives in person at 9:30 a.m. on Dec. 16 to learn the unique insights Shlomo Mena has gleaned from decades of experience. The number of places is limited, follow the link in the comments to reserve your spot. Rafi Shavit Zohar Zehavi Rafi Montias Shai Melcer Noam Keidar Liat Aharon Pollak