DSI to Exhibit at MD&M West February 5-7, 2019 ANAHEIM, CA Booth # 849
MD&M West connects you with thousands of advanced design and manufacturing professionals for three days of industry immersion. Source from the world's largest collection of medtech suppliers. Connect with over 20,000 engineers and executives who are ready to forge business partnerships. Learn from industry luminaries presenting their insights. This is your chance to find answers to your current medtech challenges — from prototyping to full-scale manufacturing — while keeping up with the latest innovations reshaping the industry
Medical Software Development Essentials
7:30 am - 4 pm Tuesday, January 23 University Enterprise Labs - UEL 1000 Westgate Drive | St Paul 55114 | 2nd Floor - West Entrance, please
https://www.uelmn.org/single-post/2017/10/30/Medical-Software-Development-Essentials Developing software in compliance with the FDA Design Control regulations and international standards is challenging. This one-day course provides background and suggestions for developing software in a manner that meets applicable FDA guidance documents and international standards, such as IEC 62304. Discussions will center on key topics such as:
Additionally, there will discussion and insight on the recently issued FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability that are impacting software development. There will also be time dedicated to discussing options for bringing legacy software device and systems into compliance with new regulations. Interactive group discussion will be encouraged to facilitate learning.
This one-day course will cover aspects of a broad range of subjects in the area of medical software development. Depth of discussion will be driven by time and attendee interest. Follow on programs with more detail may be offered if interest is shown by attendees. Intended Audience Software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with FDA regulations and international standards. This course is also appropriate for people who are new to the medical device industry.