REGULATORY FRAMEWORK FOR SOFTWARE AS A MEDICAL DEVICE (SAMD) AND MEDICAL DEVICE SOFTWARE (2020 AND COVID-19 PANDEMIC UPDATE) 🗓

— recent regulatory changes as they apply to Medical Device software and how businesses can best prepare for upcoming regulatory submissions.

Webinar
On the web Map

OC EMBS
register
Speaker: Luis Jimenez, Vice President of Business Development for BrandwoodCKC and President of OCRA (Orange County Regulatory Affairs)
Webinar Date: August 31, 2020 6:30PM

Location: on the Web
Cost: none
RSVP: VIRTUAL TECHNICAL TALK: Must register to receive Webinar link
Event Details & Registration: IEEE

Summary:
During this presentation we will cover:

– Impact that Covid-19 is having to these types of devices and possible Emergency Use Authorization (EUA) pathways

– Specific regulatory challenges that the non-physical nature of software raises

– Review of the definition and distinction between a SaMD and medical device software

– International Medical Device Regulators Forum (IMDRF) recent developments

– EU Medical Device Regulation (MDR) required changes

– Discussion of FDA’s pre-certification program for SaMD development

– Requirements for Quality Management System and key characteristics for SaMDs

– Review of IEC 62304- Software Lifecycle Process Standard and key considerations for Design History File

– Clinical Evaluation considerations of SaMDs