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 […]
/wp-content/uploads/2019/10/logo.png00MDIC Communications/wp-content/uploads/2019/10/logo.pngMDIC Communications2019-12-03 11:25:012019-12-03 11:25:01MDIC Releases Case for Quality CAPA Process Improvement Whitepaper
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.
/wp-content/uploads/2019/10/logo.png00NWG/wp-content/uploads/2019/10/logo.pngNWG2019-10-21 07:37:082019-11-01 09:56:50MDIC Awarded Funding for Expansion of Case for Quality and Cybersecurity Threat Modeling
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 […]
/wp-content/uploads/2019/10/logo.png00NWG/wp-content/uploads/2019/10/logo.pngNWG2019-09-24 07:35:462019-11-04 10:49:44FDA Releases Case for Quality Pilot Program Report, Seeks Feedback
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 […]
/wp-content/uploads/2019/10/logo.png00MDIC Communications/wp-content/uploads/2019/10/logo.pngMDIC Communications2019-09-19 14:54:322019-09-19 14:55:22NESTcc Named One of the First Collaborative Communities with FDA Participation
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 […]
/wp-content/uploads/2019/10/logo.png00MDIC Communications/wp-content/uploads/2019/10/logo.pngMDIC Communications2019-08-21 13:14:462019-11-06 09:40:45MDIC seeks participation in new digital pathology and AI collaborative effort
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 […]
/wp-content/uploads/2019/10/logo.png00MDIC Communications/wp-content/uploads/2019/10/logo.pngMDIC Communications2019-08-14 09:26:032019-11-06 09:34:59MDIC releases first of three resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials
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 […]
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 […]
https://mdic.org/wp-content/uploads/2019/06/nadim-yared.jpg12001000MDIC Communications/wp-content/uploads/2019/10/logo.pngMDIC Communications2019-06-12 13:48:592019-06-12 13:48:59CVRx President and CEO Nadim Yared Named Chairman of the MDIC Board of Directors
MDIC is excited to announce the release of our first annual report and share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include […]
Today, NESTcc announced 12 new Real-World Evidence (RWE) Test-Cases. These projects will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and submitting organizations, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers. NESTcc’s Test-Case portfolio now includes 20 projects that span the Total Project Life […]
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 […]
MDIC Releases 2018 Annual Report
MDIC is excited to announce the release of our first annual report and share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include […]
NESTcc Announces 12 New Real-World Evidence Test Cases
Today, NESTcc announced 12 new Real-World Evidence (RWE) Test-Cases. These projects will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and submitting organizations, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers. NESTcc’s Test-Case portfolio now includes 20 projects that span the Total Project Life […]