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EFS Working Groups Update 2 Key Resources
The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources. Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an […]
FDA VIP Program Guidance Released
The Draft Guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” was published today in the Federal Register for a 60-day public commenting period. “The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices […]
MDIC Publishes Leadership Engagement Survey
Program Purpose: The Medical Device Innovation Consortium is a public/private collaboration among the FDA, healthcare providers, and medical device manufacturers. The Leadership Engagement program was developed to understand the impact of leadership engagement on company performance and the quality and safety of its products. While the focus of the program is to advance the medical […]
MDIC Publishes Framework on External Evidence Methods for Medical Devices
The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing […]
MITRE and Medical Device Innovation Consortium (MDIC) Create Playbook for Threat Modeling Medical Devices
MITRE and the Medical Device Innovation Consortium (MDIC) announced the release of their co-authored “Playbook for Threat Modeling Medical Devices,” providing insights to organizations developing or evolving an approach to creating threat models in a systematic and consistent way. The playbook is available for download from MDIC and MITRE. Read the full press release. Download the playbook. Please […]
New MDIC Education Series Helps Sponsors Design IVD RWD Studies
MDIC’s Clinical Diagnostics Program has launched a new educational series to help sponsors and regulators who want to use real-world data (RWD) and real-world evidence (RWE) in in vitro diagnostic (IVD) regulatory submissions. Module 1 of the MDIC IVD RWE Education Series the series focuses on study design considerations for an IVD clinical performance study […]
MDIC Celebrates Manufacturing Day with Release of Advanced Manufacturing White Paper
The Medical Device Innovation Consortium (MDIC) joins manufacturers and organizations across the country in celebrating Manufacturing Day 2021. MDIC today released its white paper The Road to Advanced Manufacturing in the Medical Device Industry. The white paper illustrates how a digitalization roadmap can guide a medical device company in its journey to digitally transform its […]
Medical Extended Reality Devices Working Group Seeks Subgroup Participants
The MDIC Medical Extended Reality (MXR) working group will be working to develop a framework to support the safety and effectiveness of 3D-capable MXR devices for surgical planning and procedures, including open and minimally-invasive surgery. The working group currently has four subgroups started to work on the project deliverables which includes: Terminology Subgroup Image Quality […]
MDIC Launches Digital Health Initiative
MDIC announced today the launch of its Digital Health initiative. The range of digital health-related efforts crosses over several existing programs at MDIC, including Data Science and Technology, Clinical Science, and NESTcc. This launch of this new Digital Health initiative recognizes the convergence of connectivity, information, and software in these active programs and provides an […]
MDIC Adds New Board Chair and New Board Members
The Medical Device Innovation Consortium (MDIC) today announced that Dr. Jijo James, Chief Medical Officer, Medical Devices and Global External Innovation at Johnson & Johnson, has begun his role as chair of the MDIC Board of Directors. Additionally, MDIC has added three new members to their Board of Directors: Kevin Sayer, Chairman, President and CEO […]