MassMEP Medical Device Development Series (Updated - New Dates!)
MassTech’s Chief Investment Strategist Ben Linville-Engler facilitates this three-part workshop series hosted by MassMEP.
Note the updated dates.
Medical Device Development Workshop - Three-Part Virtual Series Kicks Off on October 12.
The three-part workshop kicks off on October 12 from 9-11 a.m. and continues on October 19 and November 2.
Session 1: Architecting Trust
October 12, 9-11 AM
Case Introduction – MA Manufacturing Emergency Response Team (MERT)
Topics Covered – Crisis Response, Systems Thinking, System Engineering, Stakeholder Value Mapping, and Medical Device Product Lifecycle
Session 2: A Case for Quality
October 19, 9-11 AM
Topics Covered – FDA Regulatory Pathways, Quality Management (ISO 13485), and Risk Management (ISO 14971)
Session 3: The Human Element
November 2, 9-11 AM
Form-Function-Frequency, Stakeholder-Connected Value Statement, and Patient-User-Product Safety (IEC 62366 and IEC 60601-1)
Sessions tailored to:
Production development, manufacturing, technical, or executive professionals interested in learning more about medical device development and commercialization;
Entrepreneurs actively engaged in or considering a medical device startup; and
Ecosystem partners interested in understanding more about how they can support medical device manufacturers and developers throughout the total product lifecycle.
Goals for the series:
“Help those that are new to, or considering, medical device development understand more about the total product life cycle”;
“Introduce foundational concepts of FDA quality management and regulatory requirements and pathways”;
“Provide those working in startups, or interested in engaging with startups, a roadmap and resources for further learning”;
“Share application of systems thinking to multidisciplinary problem solving, model-driven engineering, design, and strategic decision making from MIT”; and
“Connect attendees to share knowledge and experiences and enable professional networking.”