Case for Quality (CfQ) Stakeholder Forum
What is the need?

FORUM PARTICIPATION
The medical device industry’s responsibility is to provide high-quality,
safe, and effective medical devices, and the FDA must oversee and
work with the medical device industry to ensure the continued
availability of high-quality, safe, and effective devices. The current
interactions between these two systems do not fully and consistently
enable either party to accomplish these goals
Forum Participation is open to a
What is the goal of establishing the Case for Quality Stakeholder
broad set of individuals with an
Forum?
interest in advancing the Case for

Identifying and promoting manufacturers’ implementation of
practices that result in high-quality medical devices, and evaluating
FDA regulatory approaches to promote alignment with these
practices.
Expanding engagement with a broad range of stakeholders about defining
requirements for device quality and adopting strategies to promote device
quality.
creating positive change.
Participants should be prepared to
actively participate in, and dedicate
their organization’s resources to,
relevant to their areas of interest and
expertise.
leading to the development and communication of actions
recommended for FDA, manufacturers, and other stakeholders.

organizations & committed to
Forum participants will identify challenges and opportunities to
promote device quality. Participants will take on a variety of projects,

leaders in their respective
working groups and other efforts
What will we be the output of the Forums?

Quality. Participants should be
White Paper on changes needed to improve overall level of quality,
Individuals interested in participating
in the Forum, should register at
http://mdic.org/case-for-qualityforum/
which will benefit stakeholders such as hospitals, payers, health care
Selected participants will be notified
providers, and patients from increased product quality and the
by MDIC.
increased confidence that the devices they rely on will perform as
The first Forum meeting will be
intended.
March 24, 2015 in Washington, DC.
Communication tools to allow CEOs and other high level industry
Future meetings will build on the
management a better understanding of the value of quality
outputs of the first meeting and will
investments.
be scheduled about every 2 months.
Working groups are expected to meet
offline between Forum meetings.
Medical Device Innovation Consortium (MDIC)
1550 Utica Avenue South, Suite 740
St. Louis Park, MN 55416