Webinar On-Demand
The mandatory nature of a regulatory-enabled process and the practical considerations of product design often create an undesirable tension between regulatory and development groups.
The regulatory discipline needs a clear evolution of design inputs to design outputs with evidence and substantial justification. While developers may be prone to iterative solutions, which in turn, expose additional, nuanced needs. The intersection of these native tendencies creates a tension that can be counterproductive and obstructive to medical device development if not addressed.
Register for this free, in-depth webinar with partner Greenlight Guru where we attempt a frank depiction of this collision of work practices, and focus on remedies in the form of processes, tools and approaches, that bridge the gap between development and regulatory.
The regulatory discipline needs a clear evolution of design inputs to design outputs with evidence and substantial justification. While developers may be prone to iterative solutions, which in turn, expose additional, nuanced needs. The intersection of these native tendencies creates a tension that can be counterproductive and obstructive to medical device development if not addressed.
Register for this free, in-depth webinar with partner Greenlight Guru where we attempt a frank depiction of this collision of work practices, and focus on remedies in the form of processes, tools and approaches, that bridge the gap between development and regulatory.
Some topics that will be covered include:
- Leveraging prototyping
- Single source of truth in requirements
- Development prerequisites
- Managing change
About the Presenter
Milton Yarberry
Milton Yarberry is the Director of Medical Programs for Integrated Computer Solutions, Inc (ICS). He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers.