MDIC releases list of top medical technology conferences for 2020

In a rapidly growing industry, it can easily become challenging to keep up with all of the events that are hosted each year. Whether you’re looking to network with other industry professionals, learn more about the latest device regulations, or become more educated on industry-related topics, there are countless events to choose from. To make […]

MDIC Announces Two New Board Members

The Medical Device Innovation Consortium (MDIC) is pleased to announce the addition of two new members to the Board of Directors: Jean Slutsky and Gary Johnson. The Board provides leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies. Jean R. Slutsky is the Chief Engagement and Dissemination Officer […]

MDIC Releases Case for Quality CAPA Process Improvement Whitepaper

MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from MDIC, the medical […]

MDIC Awarded Funding for Expansion of Case for Quality and Cybersecurity Threat Modeling

MDIC announced today that it has been awarded $2.8 million in funding by the U.S. Food and Drug Administration (FDA) for the expansion of the Case for Quality and medical device cybersecurity programs. Read the full press release here.

FDA Releases Case for Quality Pilot Program Report, Seeks Feedback

MDIC, on behalf of the U.S. Food and Drug Administration (FDA), is seeking public comments on a new report from FDA’s Case for Quality program, Voluntary Manufacturing and Product Quality Pilot Program Results. FDA engaged with MDIC in 2014 to develop an ongoing forum to bring stakeholders across the medical device ecosystem together to collaborate on […]

NESTcc Named One of the First Collaborative Communities with FDA Participation

The U.S. Food and Drug Administration (FDA) today announced that the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has achieved recognition as one of the first collaborative communities with participation by the FDA’s Center for Devices and Radiological Health (CDRH).  CDRH identified participation in […]

MDIC seeks participation in new digital pathology and AI collaborative effort

MDIC, FDA and Digital Pathology Association (DPA) are working to prioritize the areas of Digital Pathology and AI where MDIC can bring industry, users, government, insurance companies, and patients together to collaboratively work on several new projects. This alliance aims to work on: Temporary framework to synergize and tackle larger scale projects Harmonizing & standardizing […]

MDIC releases first of three resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials

MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year. MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient […]

MDIC Releases IVD Clinical Evidence Framework

MDIC’s Clinical Diagnostics Program today released the Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics. This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working […]

CVRx President and CEO Nadim Yared Named Chairman of the MDIC Board of Directors

MDIC announced today that CVRx’s President and CEO Nadim Yared has been named chairman of the MDIC Board of Directors and Executive Committee for a two-year term. Yared has served on the MDIC Board of Directors since 2013. He will succeed Abiomed President and CEO, Michael Minogue who will remain on the Board. Read the […]