MDIC Releases Report on Medical Device Cybersecurity, Advancing Coordinated Vulnerability Disclosure
ARLINGTON, Va.–The Medical Device Innovation Consortium (MDIC) today released a report encouraging the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety. “This paper advances an incredibly important topic in medical device cybersecurity—the adoption of coordinated vulnerability disclosure policies and processes,” […]
Case for Quality Working Groups
MDIC is currently looking for volunteers to participate in four new working groups aimed to continue the advancement of the Case for Quality. Since 2015, MDIC has been supporting FDA’s launch of the Case for Quality which was developed to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical […]
NESTcc Funding Opportunities
The National Evaluation System for health Technology Coordinating Center (NESTcc) has announced two new funding opportunities, including a call for concepts for its second round of test-cases as well as an opportunity to submit targeted test-case concepts leveraging patient-generated health data for regulatory purposes. NESTcc is soliciting test-case concepts from medical device stakeholders to further develop and […]
New Resources: Surrogate Samples Education
Upon creation of the Surrogate Sample Framework, MDIC’s working group developed a comprehensive set of educational materials to assist with shared terminology and principles for the acceptable use of surrogate samples between FDA reviewers and IVD test developers. The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for […]
FDA releases guidance to promote IVD device data interoperability and RWE efforts
On June 15th, 2018, FDA released the Guidance for Industry and FDA Staff “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” IVD LOINC Guidance to encourage consistency in the coding of IVD tests by addressing questions regarding the distribution of LOINC codes by IVD test manufacturers to users. This guidance helps provide regulatory […]
NESTcc Data Quality Subcommittee and Methods Subcommittee
The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. These subcommittees will develop data quality and methodological standards for NESTcc Network Collaborators – the organizations partnering with NESTcc to generate and analyze […]
MDIC’s involvement in the Case for Quality
MDIC’s involvement in the Case for Quality highlighted in MedTech Insight article: Chasing Quality Isn’t Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
Join MDIC at the 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from May 19 – 23
Join MDIC at the 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from May 19 – 23 in Baltimore, Maryland. MDIC initiatives will be featured throughout the conference, including a patient-focused workshop, What Is Patient-Centered and Fit-For-Purpose Patient Preference Information? on May 22 from 3:45-4:45p.m. EST. MDIC Program Director Stephanie Christopher, MA, along with Anindita Saha, BSE (CDRH), Brett […]
NESTcc Launches a Call for Experts to its Data Quality and Methods Subcommittees
NESTcc Launches a Call for Experts to its Data Quality and Methods Subcommittees – The National Evaluation System for health Technology Coordinating Center (NESTcc) is seeking experts to participate in its Data Quality and Methods subcommittees. If you are an expert in the medical device space or if you have participated in the PCORI Methodology Committee, PCORnet, […]
