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, […]

Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?

Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?

Medical Device Innovation Consortium (MDIC) Announces Pamela Goldberg, MBA Appointed as President and Chief Executive Officer (CEO)

Medical Device Innovation Consortium (MDIC) Announces Pamela Goldberg, MBA Appointed as President and Chief Executive Officer (CEO)

What if FDA and Medtech Worked Together on Quality?

What if FDA and Medtech Worked Together on Quality? An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.

NESTcc Demonstration Projects

The National Evaluation System for health Technology Coordinating Center (NESTcc) has selected 11 demonstration projects for their potential to provide proof of concept for innovative and scalable approaches to Real-World Evidence (RWE) generation across the medical device total product life cycle (TPLC). Executive Director of NESTcc Rachael L. Fleurence, PhD explains, “the lessons from the NESTcc demonstration projects will […]

FDA Strategic Roadmap for 2018 and Beyond

Commissioner, Dr. Scott Gottlieb, released the FDA Strategic Roadmap for 2018 and Beyond. The Roadmap includes a vision for Computer Modeling including to develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.