27a Midstate Dr
Auburn, MA 01501
USA
In person, September 28, October 5 & 12 from 9-11 AM each week.
Join us for this three part workshop series for Medical Device Development. Do you as a Medical Device Manufacturer fall into one of the categories below? If yes, we will see you in September!
- 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
- Ecosystem partners interested in understanding more about how they can support medical device manufacturers and developers throughout the total product lifecycle
Medical Device Development Series:
Session 1: Architecting Trust
September 28, 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 5, 9-11 AM
- Topics Covered – FDA Regulatory Pathways, Quality Management (ISO 13485), and Risk Management (ISO 14971)
Session 3: The Human Element
October 12, 9-11 AM
- Form-Function-Frequency, Stakeholder-Connected Value Statement, and Patient-User-Product Safety (IEC 62366 and IEC 60601-1)
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
- Connect attendees to share knowledge and experiences and enable professional networking
Workshop facilitator: Ben Linville-Engler
Ben is the Chief Investment Strategist and Program Executive at MassTech where he works across the agency’s programs and funds to manage strategic investments into emerging technologies, align investments with growth strategies, and identify new opportunities for growth to ensure maximum impact on the Commonwealth’s tech and innovation economy. Ben also provides program oversight for the agency’s Center for Advanced Manufacturing (CAM), MassCyberCenter, and the Massachusetts eHealth Institute (MeHi).
To register to attend this event, you must register through the button below. When registering for this event, you are registering for the three (3)-part workshop that will be held in person, September 28, October 5 & 12 from 9-11 AM each week. This is the only registration link for this workshop.
