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SUMMARY:Beauty Istanbul 2025 - Istanbul
DESCRIPTION:Keen on Beauty Care? Let’s meet at Beauty Istanbul\, one of the largest cosmetics exhibitions worldwide! Our Mission? Helping cosmetics brands seamlessly adapt to global compliance standards.Why Meet Us at Beauty Istanbul?✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updatesLet’s connect and discuss how we can support your regulatory needs. Book a meeting with us in advance and see you at your booth!We look forward to meeting you at Beauty Istanbul!
URL:https://www.obelis.net/events/beauty-istanbul-2025-istanbul/
CATEGORIES:Exhibitions
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SUMMARY:FDA U.S. Agent and Submissions
DESCRIPTION:Join us for this essential webinar. Whether you’re preparing your first submission or trying to keep up with evolving requirements\, we’ve got the insights to help you move forward with certainty.Webinar highlights include: \n\n\n\n✅Cybersecurity  \n\n\n\n✅U.S. Agent and Official Correspondent \n\n\n\n✅Establishment Registration and Device Listing \n\n\n\n✅Submissions (GUDID\, 510k and others) \n\n\n\n\n\n\n\n🎯 When: May 8 | 16:30-17:30 CET \n\n\n\n📌 Where: Online | Zoho Webinars  \n\n\n\n🎬 Guests: Jay Mansour (Mansour Consulting LLC) and Tommaso Poles (Obelis Group) \n\n\n\n \n\n\n\n \n\n\n\n\nRegister here!
URL:https://www.obelis.net/events/fda-u-s-agent-and-submissions/
CATEGORIES:Webinars
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DTSTART;TZID=Europe/Brussels:20250526T000000
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SUMMARY:IVDR Legacy Extension Deadline – May 2025
DESCRIPTION:For in vitro diagnostic (IVD) manufacturers navigating the transition to the In Vitro Diagnostic Regulation (IVDR)\, a key deadline is approaching. The IVDR legacy extension applies only if manufacturers meet specific requirements: \n\n\n\nSubmission of an application to a Notified Body \n\n\n\n✅ Class D devices (high-risk IVDs that were self-certified under IVDD but now require a Notified Body under IVDR)- by 26 September 2025 \n\n\n\n✅ Class C devices – by 26 May 2026 \n\n\n\n✅ Class B & Class A sterile devices – by 26 May 2027 \n\n\n\n✅All classes of IVD legacy devices – Implementation of an IVDR-compliant Quality Management System (QMS) – by 26 May 2025 \n\n\n\nFailing to meet these and existing legacy conditions means the extension will not apply\, and full IVDR compliance will be required. Manufacturers should act now to ensure a smooth transition and avoid market disruptions. \n\n\n\nIs your company on track for compliance? Let’s discuss how to navigate this critical regulatory shift. \n\n\n\n \n\n\n\n\n\n\n\n\nLegacy device manufacturers: Important deadlines & steps · MDlaw – Information platform on European medical device regulations: Winning with IVDR: Compliance Strategy\, Class C Pathways & NB Engagement
URL:https://www.obelis.net/events/ivdr-legacy-extension-deadline-may-2025/
CATEGORIES:Deadlines
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