Arazy Group Consultants Inc.

🔹 What’s New? Starting October 1, 2025, electronic submissions will be mandatory for De Novo requests. This aligns with the FDA’s commitment to streamline regulatory processes and enhance review efficiency. 🔹 Key Highlights: ✅ Detailed technical standards for crafting electronic submissions ✅ Guided templates to ensure all essential elements are captured ✅ Waivers and exemptions for specific cases ✅ Future updates to the eSTAR tool, shaped by ongoing public feedback This guidance is a game-changer for MedTech innovators, making the De Novo pathway more efficient and reducing time-to-market for breakthrough devices. Want to dive deeper into how this impacts your regulatory strategy? 👉 Read our latest blog post here for a full breakdown of the new requirements, what they mean for your submissions, and how to stay ahead of the curve. https://hubs.ly/Q02XCjYv0 #MedTech #FDACompliance #DeNovoPathway #MedicalDevices #RegulatoryAffairs #eSubmissions #InnovationInHealthcare

🌎 With REGISLATE, you get immediate, real-time access to each product's market status on our dynamic Global Regulatory Map! It provides a quick yet detailed overview of each product registration stage, with estimated submission and approval dates for all registrations in progress. You can also view your product's MARI Score, a comprehensive computation that assesses your product’s safety and regulatory compliance level. It seamlessly aligns with the precise country-specific requirements of your selected market and reveals the timeline required to complete the submission and the average expected review time by the authorities. The higher the score, the higher your potential success in completing registration in the given country by the effective time suggested by the system! This score can be used to monitor current progress and for future market access. Start your product registration TODAY in less than a minute, and find out your MARI Score at https://hubs.ly/Q02XBg0T0 #ArazyGroup #MARIScore #REGISLATE #ProductRegistration #RegulatoryAffairsTechnology #MedTech #GlobalSolution #RegulatoryCompliance

🚀 Meeting With Us Before MEDICA Could Unlock Huge Opportunities—If You Do This... The real key to MEDICA success might be what happens before you even get there. Want to be in the know? Discover what it takes to get ahead of the competition before the exhibition. 👇 https://hubs.ly/Q02XsSNF0 #SalesGrowth #GlobalMarkets #MEDICA2024 #ArazyGroup

🚩Drive Your MedTech Success with Arazy Group With over 20 years of expertise, Arazy Group is the trusted partner for MedTech companies and regulatory affairs professionals seeking streamlined, reliable product registration and market access worldwide. 🚀 Join industry leaders in accelerating your medical device and IVD approvals across key regions, including the U.S., and unlock growth with our advanced global platform. 🌎 Ready to expand? Discover seamless registration and market access with Arazy Group. https://hubs.ly/Q02XdH8Z0 Learn more about our Global IVD & Medical Device Registration and Market-Access Platform today. https://hubs.ly/Q02XdHB90 #ArazyGroup #RegTech #MedTech #RegulatoryAffairs #ProductRegistration #GlobalMarketAccess #USMarket

💼 Why Smart Companies Aren't Booking a Meeting With Us at MEDICA... Think scheduling your calendar full of meetings at MEDICA is the best strategy? Think again. There’s a reason why you might not want us on your schedule during the exhibition. Want to know why? 👇 https://hubs.ly/Q02WWnkk0 #MarketEntry #SalesStrategy #MEDICA2024 #MedtechSuccess #ArazyGroup

🔉Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has introduced groundbreaking guidelines for registering Software as a Medical Device (SaMD), effective July 1, 2024. All medical devices, including SaMD, now require mandatory registration via the NAPAMS portal. The full report: https://hubs.ly/Q02WWlM80 ✔️This pivotal change defines SaMD as software intended for medical use independently of any hardware, with a strong emphasis on meeting classification and technical validation standards. Compliance demands thorough clinical evaluation, proper labeling, and comprehensive documentation—signifying a major step forward in Nigeria’s regulatory landscape. Have questions? Need assistance or clarification? Contact us today! https://hubs.ly/Q02WWnkf0 We speak Regulatory. #NAFDAC #SaMD #MedicalDevices #RegulatoryCompliance #HealthTech #MedicalSoftware #NigeriaHealthcare #DigitalHealth #NAPAMS #HealthcareInnovation #ArazyGroup

Tackling Swiss regulations? Arazy Group has you covered. 🇨🇭 With over two decades of expertise, we make Swiss market access straightforward for MedTech companies. From meeting local regulatory requirements to accelerating product registrations, we help you avoid hurdles and gain a smooth entry. Join leading companies achieving Swiss compliance with ease and get ready for your next market expansion. 🌏 Ready to expand globally? Learn more at https://hubs.ly/Q02WG-nj0. #MedTech #SwissRegulations #RegulatoryCompliance #GlobalMarketAccess #ArazyGroup

✨ For those celebrating, we wish you a bright and prosperous Diwali! ✨ May this festival of lights bring new opportunities, success, and growth. Happy Diwali from all of us at Arazy Group! 🌟 #HappyDiwali #Diwali2024 #FestivalOfLights #GrowthAndProsperity

🎃👻 Not too late to Reach Your Ghouls! 👻🎃 Looking to bring your medical device or IVD to life in over 140 countries? Don’t let your product’s potential haunt you! With REGISLATE® by Arazy Group, you’ll have a powerful ally that handles global registration with a spooky level of ease. 🔹 Regulatory Information Management: Get the full country-specific requirements for your submission at your fingertips. 🔹 Regulatory Process Management: Track deadlines, timelines, and every step with precision—before they creep up on you! 🔹 Regulatory Strategy Management: Map your product’s path to success with our tracking, compliance, and real-time reporting tools. No tricks here, only treats: REGISLATE® uses the Pareto Principle, automating 80% of the work so you can achieve 100% of your goals with less effort. 💀 Before it’s tooo late... Start your free trial now and conquer the regulatory world before it gets spooky! 🕸🕷 https://hubs.ly/Q02WtdjR0 #MedTech #ArazyGroup #RegulatoryCompliance #Regislate #HappyHalloween #RegTech #Q4Goals

⏳ Don't Miss Out! The Post-MEDICA Strategy No One Talks About Timing is everything in medical device sales, especially when expanding globally. Attending MEDICA is great, but maximizing your growth requires a post-show strategy most overlook. We'll reveal a costly meeting mistake and show you the proven approach to unlock new market opportunities after MEDICA! Click here to avoid missing out: https://hubs.ly/Q02W4RZh0 #MEDICA2024 #MedicalDeviceSales #GlobalMarketExpansion #HiddenOpportunities #PostShowStrategy