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Novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.
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Timings8:00 AM - 5:00 PM (General)
| Entry FeesPaid Ticket Starts from 1199 USD View Details |
Estimated Turnout200 Delegates 10 Exhibitors | Event TypeConference |
EditionsApr 2020 5th EditionFrequency Annual | Official LinksWebsiteContact Report Error Claim this event |
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42.357764-71.060106 Venue60 School St, Boston, MA 02108, USA
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Visitor Ticket Price
| 1199 USD | Visitor/GeneralSingle Registration |
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Schedule & Agenda
Filter By| Thu, 16 Apr 08:00 AM - 08:30 AM | Registration & Breakfast | |
| Thu, 16 Apr 08:30 AM - 08:45 AM | Opening Ceremony Welcome Speech with an Introduction of ComplianceOnline & Summit | |
| Thu, 16 Apr 08:45 AM - 09:10 AM | Keynote FDA Enforcement – Outlook & Implications FDA Enforcement – Outlook & Implications | |
| Thu, 16 Apr 09:15 AM - 09:45 AM | Keynote CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance | |
| Thu, 16 Apr 09:45 AM - 10:15 AM | Keynote Current Healthcare Eco System: Challenges & Opportunities Ensuring HIPAA security in today’s health IT environment requires HDOs hit a daily trifecta of HIPAA compliance, cyber security, and medica...continue reading | |
| Thu, 16 Apr 10:15 AM - 10:35 AM | Session Global Medical Device Regulations - US, EU, Canada, Brazil, China, Japan, Mexico, Russia, South Korea, Taiwan This session will cover:High level review of US GMP regulations and those significant GMP regulations worldwide regarding quali...continue reading | |
| Thu, 16 Apr 10:30 AM - 10:45 AM | Break Networking Break | |
| Thu, 16 Apr 10:45 AM - 11:20 AM | Session GDPR 2020: The evolution of general data protection and the rights of individuals over their own data. Nearly two years after becoming effective, the EU General Data Protection Regulation (GDPR) has had significant effects on companies around...continue reading | |
| Thu, 16 Apr 11:25 AM - 12:00 PM | Keynote Artificial Intelligence in Medical Device | |
| Thu, 16 Apr 12:00 PM - 01:00 PM | Lunch Lunch | |
| Thu, 16 Apr 01:00 PM - 01:35 PM | Session FDA Communication Power Tools The US Food and Drug Administration offers a range of mechanisms to communicate with premarket review staff. The timing of communication an...continue reading | |
| Thu, 16 Apr 01:40 PM - 02:00 PM | Session Medical Device Outsourcing, Supply Chain Management and new Foreign Trade Problems for Import/ Export Business Global markets create new and costly demands for a device import/export business. Firms must consider and update their short and long-term ...continue reading | |
| Thu, 16 Apr 02:00 PM - 02:30 PM | Session Vendor and Supplier Qualification and Selection. Vendors and suppliers present new risks that require a systematic evaluation of their suitability for your product. You sh...continue reading | |
| Thu, 16 Apr 02:30 PM - 02:45 PM | Break Networking Break | |
| Thu, 16 Apr 02:45 PM - 03:15 PM | Session 3D Printed Medical Implants – Past, Future and… Present #Track A - Sessions The talk will provide audience with perspective on 3D printed medical implants & instruments current and future state. Care will be taken t...continue reading | |
| Thu, 16 Apr 02:45 PM - 03:15 PM | Session MDR Implementation - Status, Next Steps and (revised) Timelines #Track B - Sessions How to prepare for May 26, 2020 for devices using the soft transitionArt 120(3)Economic OperatorsPMS/Vig...continue reading | |
| Thu, 16 Apr 03:25 PM - 03:50 PM | Session Wearable Device #Track A - Sessions | |
| Thu, 16 Apr 03:25 PM - 03:50 PM | Session Software as a Medical Device - What to consider? #Track B - Sessions Software as a medical device under MDRApps as medical devicesSoftware as part of a medical deviceCla...continue reading | |
| Thu, 16 Apr 04:00 PM - 04:40 PM | Keynote FDA Electronic Submission Process | |
| Thu, 16 Apr 04:40 PM - 04:50 PM | Closing Ceremony Closing Mark - Next Day Plan | |
Visitor Ticket Price
| 1199 USD | Visitor/GeneralSingle Registration |
Exhibitors List
3 Exhibitors of Current Edition42.357764-71.060106
Venue
60 School St, Boston, MA 02108, USA
Boston
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