RegDesk

#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

#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

✨ 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

🎉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

#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

#GlobalRegulatoryUpdatesWithRegDesk 🌐 Join RegDesk for our latest Global Regulatory Updates. This week our 2-minute video shares important alerts from the UK and Egypt. This week's top global regulatory updates include: 1. UK- Implementation of medical devices future regime roadmap released. 2. UK- Electromagnetic compatibility regulations 2016 amended guidance. 3. Egypt- A new version of Regulatory Guide for labeling data for medical and laboratory supplies and devices, diagnostic reagents, production components and inputs has been released. Check out the video for more details! https://lnkd.in/eapas4Pw 👉 Follow RegDesk to stay up to date with our Medical Device Regulation Alerts. #RegulatoryUpdates #RegDesk #Compliance #UK #Egypt #medicaldevices #regulations #AI #RIMS

The December edition of our newsletter covers significant changes to medical device regulations in the UK, post Brexit. Learn how to manage the divergence between UK and EU regulations. Also, top alerts from Finland and EU are shared.

The regulatory landscape for medical device cybersecurity varies significantly across global markets, with each region adopting its own approach to managing risks and ensuring patient safety. Understanding these differences is essential for manufacturers to design robust, compliant strategies while safeguarding their devices from evolving cyber threats. Steps for a successful process: 1. Understand Regulatory Requirements 2. Conduct a Risk Assessment 3. Implement Secure Development Practices 4. Develop a Unified Global Cybersecurity Strategy 5. Engage Proactively with Regulatory Bodies 6. Leverage Regulatory Intelligence Platforms 7. Test and Validate Security Measures 8. Provide Post-Market Surveillance 9. Plan for Incident Response 10. Prepare Comprehensive Documentation By prioritizing cybersecurity in your regulatory strategy, you not only ensure compliance but also build trust with healthcare providers and patients, contributing to a more secure healthcare ecosystem. How is your organization addressing the cybersecurity challenge in medical device innovation? Share your thoughts and experiences in the comments below. #MedicalDevices #Cybersecurity #RegulatoryCompliance #HealthcareInnovation

Last Chance to Register! #WebinarWednesday: 🌐2024 Regulatory Roundup 🌐 December 11, 2024 at 11AM ET. ⭐ Time is running out! ⭐ Along with insights into 2025, we will discuss key changes and significant updates from 2024 including updates from US, EU, Canada, Hong Kong, Saudia Arabia, Malaysia, Australia, UK and more! Register Here: Webinar Registration - Zoom 🌍 🌎 🌏At RegDesk so far in 2024 we have had over 1140 alerts and updates in the 120+ markets we cover. Could you have missed any important alerts that could affect your medical devices? #webinar #RegDesk #regulatoryroundup #regulations #medtech #medicaldeviceregulations #compliance

#RegulatoryUpdatesWithRegDesk 🌐 USA Update: 🌎 Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: The FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. Follow: 👉RegDesk to get your Global Regulatory Updates! #regulatoryupdates #USA #RegDesk #PCCP #AI #medicaldevices #compliance #alerts