This site uses cookies to improve your browsing experience; the website may not work as expected without them. By continuing to browse this site, you consent to the use of cookies.
Accept settingsMore InfoWe may request cookies to be set on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience, and to customize your relationship with our website.
Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.
These cookies are strictly necessary to provide you with services available through our website and to use some of its features.
Because these cookies are strictly necessary to deliver the website, refuseing them will have impact how our site functions. You always can block or delete cookies by changing your browser settings and force blocking all cookies on this website. But this will always prompt you to accept/refuse cookies when revisiting our site.
We fully respect if you want to refuse cookies but to avoid asking you again and again kindly allow us to store a cookie for that. You are free to opt out any time or opt in for other cookies to get a better experience. If you refuse cookies we will remove all set cookies in our domain.
We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.
These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.
If you do not want that we track your visit to our site you can disable tracking in your browser here:
We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.
Google Webfont Settings:
Google Map Settings:
Google reCaptcha Settings:
Vimeo and Youtube video embeds:
The following cookies are also needed - You can choose if you want to allow them:
You can read about our cookies and privacy settings in detail on our Privacy Policy Page.
Privacy Policy
NESTcc Welcomes MedStar Health to Research Network
The National Evaluation System for health Technology Coordinating Center (NESTcc) today announced MedStar Health as the newest network collaborator to join its research network, partnering with the largest health provider in the D.C. region to expand its research expertise and data capabilities for medical device evaluation. Leveraging access to electronic health records, claims, and other relevant […]
MDIC releases report to help sponsors improve device clinical trials by engaging patients
Patient engagement in medical device clinical trials can lead to faster completion of studies, higher retention and compliance, and more streamlined and relevant data. Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, developed by the Science of Patient Input Participation in Clinical Trials Working Group, highlights benefits of using patient […]
MDIC seeks participants to join Medical Extended Reality Devices working group
MDIC is launching a working group on the evaluation of Medical Extended Reality Devices (MDIC MXR WG). Extended Reality (XR) encompasses augmented and virtual reality and is being explored for a wide range of medical applications including rehabilitation, mental health therapies, pain management, diagnostics, surgery, and image-guided interventions. While these applications present exciting possibilities for […]
MDIC releases report on lessons learned from the Patient Engagement Forum
Last year, MDIC hosted its Patient Engagement Forum to familiarize a diverse group of medical device stakeholders with key concepts and considerations for successful communication with patients about benefits, risks, and uncertainty associated with the use of medical devices. MDIC has compiled a report on lessons learned from the forum which is now available for […]
MDIC releases draft blueprint for fingerstick specimens for point of care in Vitro diagnostic medical devices
MDIC is seeking public comment on its Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens. This document is intended to serve as a study design blueprint for using capillary whole blood (fingerstick) data for analytical validation of IVD tests. This document […]
Project Focused on Using RWE to Convert IVD EUAs to 510(k) Underway
In 2020, MDIC’s Clinical Diagnostics program launched the ‘Open Hand’ project, a process to pave a path for using IVD Real-World Evidence in regulatory submissions. The goals of this project are to provide a transparent process to evaluate new technology and methods; capture “the how” to share with broader community while staying in the pre-competitive space […]
MDIC releases playbook of best practices for shifting organizations to a Culture Of Quality
MDIC has released its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality. Created through the Case for Quality Collaborative Community (CfQcc), the playbook aims to help organizations tailor their approach to quality by providing resources to determine which concepts, […]
MDIC seeks candidates to provide feedback on COVID-19 Patient Discussion Tool
MDIC is developing an updated COVID-19 Patient Discussion Tool to help patients better understand the implications of delaying or forgoing medical treatment during the ongoing pandemic. The aim of the tool is not to guide the patient towards a specific conclusion, but to assist them in gathering information potentially important to making a final decision. In […]
MDIC releases draft framework on External Evidence Methods for public comment
MDIC is seeking public comment on its framework External Evidence Methods: Statistical Methods for Leveraging External Data in Regulatory Decision-Making. This framework intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. It catalogs different sources of external data and traditional and novel statistical methods applicable to the design and […]
NESTcc welcomes Regenstrief Institute to Research Network
In a partnership to advance the generation of high-quality evidence in medical device evaluation, NESTcc has announced the Regenstrief Institute as the newest Network Collaborator to join the NESTcc Research Network. Based in Indianapolis, Regenstrief Institute is a global leader dedicated to improving health and healthcare through innovations and research in biomedical informatics, health services […]