Application of Agile to the Development of Medical Device Systems – September 25-27, 2019
For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems. [...]
Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – September 24-26, 2019
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during [...]
Effective Application of Agile Practices in the Development of Medical Device Software – September 23-24, 2019
Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, [...]
Manufacturing Leadership Development Series – Module 4: Team Work and Team Building – September 24, 2019 – 9 am to 12 noon ET
Teams are typically comprised of people with diverse ideas and backgrounds and will always outperform individuals when leaders understand how to build these teams and leverage the strengths of all team members. This module defines [...]