🚀 Did you know that AI-powered regulatory submissions can reduce preparation time by up to 60%? Artificial Intelligence is reshaping the landscape of regulatory submissions, offering game-changing benefits for medical device companies: • Slashing submission preparation time • Dramatically reducing errors • Ensuring global compliance with real-time updates But how exactly is AI transforming regulatory processes? And more importantly, how can you harness its power to stay ahead in an increasingly complex regulatory environment? We've just published an in-depth blog post exploring the future of AI-powered regulatory submissions. Discover practical applications, strategic advantages, and how this technology is set to redefine compliance management. 🔗 Read the full article here: https://lnkd.in/enUAZPak Don't miss out on this crucial insight that could revolutionize your approach to regulatory affairs! What's your biggest challenge in regulatory submissions? Share below, and let's discuss how AI might address it. #RegulatoryInnovation #AIinHealthcare #MedTechCompliance #RegTech #FutureofRegulatory
RegDesk
Software Development
Houston, TX 10,483 followers
The Most Comprehensive AI Enabled RIMS For MedTech Companies
About us
RegDesk transforms the way healthcare leaders make decisions. Our holistic Regulatory Information Management (RIM) system delivers cutting-edge intelligence solutions to help compliance leaders stay one step ahead of regulatory risks and changes globally. With RegDesk, you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Don't let regulatory changes become a roadblock. Global expansion has never been this simple.
- Website
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https://www.regdesk.co/
External link for RegDesk
- Industry
- Software Development
- Company size
- 51-200 employees
- Headquarters
- Houston, TX
- Type
- Privately Held
- Founded
- 2014
- Specialties
- Regulatory, Quality Management Systems (ISO 13485, 21 CFR 820), Validation, Verification Protocols & Reports, Clinical Testing, HIPPA, Quality Assurance, Compliance, Medical Device, Pharmaceutical, Submission Generator, Tracking and Reporting, Change Assessment, Standards Management, GSPR, Regulatory Intelligence, Regulatory Affairs, Distributor Collaboration, Document Management, Alerts and Notifications, Product Management, RIMS, Healthcare, and Diagnostics
Locations
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Primary
2450 Holcombe Blvd
Suite X
Houston, TX 77098, US
Employees at RegDesk
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Priya Paul (Bhutani)
Founder & CEO, RegDesk.co
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Claudia Carolina Mayer
Regulatory Affairs Specialist | Medical Devices | IVD | Quality Management | ANVISA RDC 665/2022 | ANVISA RDC 751/2022 | ANVISA RDC 830/2023 |…
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Matt Winters
Enterprise Sales Team Lead
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Pablo Ojeda
Medical Devices QA/RA Specialist | Enhancing Quality and Compliance through R&D and Innovation
Updates
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🎉 Thank you to our clients, collaborators, and team for being an integral part of our journey together. We look forward achieving great things together in 2025! 🙌 #Gratitude #ThankYou #2025Goals #RegDesk #team #clients #collaborators
🎉As we wrap up an exceptional 2024, I want to express my heartfelt gratitude to our clients, collaborators, team members, and supporters. Your trust, partnership, and dedication have been the driving force behind our success this year. We couldn't do it without each of you! We look forward to building on this momentum and achieving even greater milestones together in 2025. Wishing you a joyful holiday season and a prosperous New Year!🎉 #Gratitude #ThankYou #RegDesk #2024Reflections #2025Goals #partnerships #teammembers #collaboration
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#RegulatoryUpdatesWithRegDesk 🌐 UK: Implementation of medical devices future regulations: The UK has released a roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. Link👉: https://lnkd.in/d-6y6BtG #regulatoryupdates #RegDesk #compliance #UK #RIMS #AI #medicaldevices
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#TeamMemberSpotlight 🔦 🔦This month we are shining our spotlight on Дмитрий Скоржинский (Dmitriy) who has been at RegDesk for 1 year and 2 months as a web developer. At RegDesk, we pride ourselves on fostering a collaborative and supportive environment, and Dmitriy is always helpful and willing to tackle any project. His hard work and dedication make RegDesk a better place and we are honored to have him as part of our team. Thank you, Dmitriy, for all your time, expertise, and commitment—we are very appreciative of all you do! 👏 #teamspotlight #RegDesk #AI #Innovation #TeamMemberAppreciation #BestTeam #RIM
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#RegulatoryUpdatesWithRegDesk 🌐 Singapore: Guiding Principles for conducting Clinical Trial for Machine Learning-enabled Medical Devices (MLMD) have been released. These guiding principle address the unique challenges posed by MLMD in clinical studies. Follow: 👉RegDesk to get your Global Regulatory Updates! #regulatoryupdates #RegDesk #compliance #Singapore #GuidingPrinciples #MLMD #RIMS #AI
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#RegulatoryUpdatesWithRegDesk 🌐 Egypt: Opinion Poll on the Draft of the Second Edition of the Regulatory Guide for Procedures for Registering and Issuing Import Approvals for Laboratory and Diagnostic Reagents. Representatives of laboratory and diagnostic reagents companies and factories are kindly requested to participate in the opinion poll for the draft regulatory guide referred to by filling out the special form to the following email: md.techoffice@edaegypt.gov.eg before 12/18/2024. Follow: 👉RegDesk to get your Global Regulatory Updates! #regulatoryupdates #RegDesk #Egypt #compliance #medicaldevices #guidance #RIMS #AI
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#GlobalRegulatoryUpdatesWithRegDesk 🌐 Join RegDesk for our latest Global Regulatory Updates. This week our 2-minute video shares important alerts from the Canada and South Africa. This week's top global regulatory updates include: 1. Canada- There is a new version of the Guide to Recall Medical Devices (GUI-0054). 2. South Africa- There is a Guideline for Completing Medical Device Adverse Event Form available. 3. Canada- There is a new version for Guidance on Medical Device Establishment Licensing (GUI-0016). Check out the video for more details! https://lnkd.in/e7dgbFnn 👉 Follow RegDesk to stay up to date with our Medical Device Regulation Alerts. #RegulatoryUpdates #RegDesk #Compliance #Canada #SouthAfrica #Guidance #medicaldevices #RIMS
Global Regulatory Updates from Canada and South Africa
https://www.youtube.com/
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✨ Happy Holidays from our RegDesk team! ✨ As the year draws to a close, we want to take a moment to express our gratitude to our clients, partners, and regulatory community. Your support and collaboration have made 2024 a truly remarkable year! We wish you a joyful holiday season filled with warmth, happiness, and time with loved ones. May the holiday spirit shine bright on each of you! Here’s to an exciting and successful 2025 ahead! Thank you for being part of our journey. 🌟 #HappyHolidays #Gratitude #NewYear2025 #ThankYou
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🎉For the month of December, we would like to celebrate our team member anniversaries! 🎉 A huge congratulations to our amazing team members: 3️⃣ Years: Serhii Voloshyn Full-Stack Developer 2️⃣ Years: Mariia Stolbtsova QA Engineer 2️⃣ Years: 施昊 (Howe) Software Developer 2️⃣ Years: liu bing (Luke Liu) Senior Full-Stack Developer We are incredibly grateful to have you as part of the RegDesk team! Thank you for your hard work, dedication, and unwavering commitment. We look forward to continuing our journey of collaboration, growth, and success in the years to come. We couldn’t achieve any of this without you! #WorkAnniversary #TeamRegDesk #AI #Automation #team #HealthcareInnovation #Celebration #TeamMember #together
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#RegulatoryUpdatesWithRegDesk 🌐 Egypt: Regulatory Guide for Labeling Data for Medical and Laboratory Supplies and Devices, Diagnostic Reagents, Production Components, and Inputs This guide concerns the minimum data that must be available on the labels of medical and laboratory supplies and devices, diagnostic reagents for trading in the Arab Republic of Egypt, and production components and inputs imported for use in production Version 2.0. Follow: 👉RegDesk to get your Global Regulatory Updates! #regulatoryupdates #RegDesk #compliance #Egypt #Guide #medicaldevices #RIMS #AI