Virtual Conference
Major changes are planned for Medical Devices. 21CFR 820 is adopting ISO 13485 additionally with a significant amount of hardware and software, Cybersecurity is gaining paramount interest. Additionally the Medical Devices are adopting the V Model as shown by ISO 62304.
Digitalization of EV & AV Product Development
| Digitalization of Product Development for Medical Device Standards |
| Culture Change towards "Digitalization" Chad Kymal- CTO, Omnex Inc.  |
| Digitalization of NPD Juliane Albuquerque - Quality Systems Manager, Android Industries |
| NPD Platform Features released in SP 11.x and Glimpse of End of Year Release Plan Andrei Samoila - Director Implementations, Omnex Systems Feedback and Q & A |
| QHSE Platform Features released in SP 11.x and Glimpse of End of Year Release Plan Sreenadh Balakrishnan - Implementer QHSE Feedback and Q & A |
| Changes to Medical Devices Standards |
| FDA’s Proposed Changes to 21 CFR 820
Michael Checketts - Omnex Representative for TC210 for Medical Devices
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| Cybersecurity Mandates for Medical Devices
Chad Kymal - CTO, Omnex Inc. |
| ISO 62304 – Software Life Cycle Processes, the Challenges for Medical Devices
Pete Sparacio - Head of Global Quality & Regulatory Affairs |
| Recent Developments in IMDRF Standards including Cybersecurity
Lawson Cline - Omnex Consultant |