Digitalization of Product Development & Medical Device standards changes
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
|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