MDIC is the only public-private partnership (PPP) developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.

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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 […]

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