Lana Feng, Ph.D.
CEO and Co-Founder, Huma.AI
Huma.AI has announced the launch of a new EU MDR and IVDR Resource Center on MedTech Intelligence (MTI). The MTI Resource Center is a free community for sharing news, guidance, and expert insights about the changing Medical Device and In Vitro Diagnostic regulatory landscape.
The Stakes Are High
According to some industry estimates, the cost of EU MDR and IVDR compliance could be as much as five percent of annual revenue for MedTech companies, but that is only the beginning.
"With resources hard to come by, we wanted to create a place where regulatory professionals could easily access authoritative content," said Lana Feng, Ph.D., CEO and Co-Founder of Huma.AI.
The Resource Center features a mix of current news, video interviews, blog articles, select industry events, and other useful information related to the EU MDR and IVDR transition.
"Our goal with the resource center is to raise the level of discourse and understanding around the challenges and opportunities the EU Regulations have created," said Dr. Feng.
Watch Expert Interviews
These days, expert advice on EU MDR and IVDR can be very costly—if you can find it at all.
With notified bodies, MedTech manufacturers, and government agencies all competing to secure experts from the same talent pool, understanding EU MDR and IVDR is one of the primary challenges for many organizations.
Huma.AI is building a robust network of experts to help fill in knowledge gaps. The MTI Resource Center's Expert Spotlight features subject matters experts discussing the various challenges of the transition, including:
- Clinical Evidence
- Risk Management
- Post-Market Intelligence
- State of the Art
- Systematic Literature Reviews
- Life Cycle Management
- And More.
Developed explicitly for MedTech professionals responsible for managing the regulatory transition, the EU MDR and IVDR Resource Center is an all-in-one community for supporting the varied challenges of compliance.
Helpful Guidance Documents
Finding useful EU MDR and IVDR guidance documents is time-consuming.
The MTI Resource Center features links to current MDCG guidance documents and other authoritative resources. This section will be updated regularly as new guidance documents are published.
Readers are also encouraged to submit guidance documents and other suggestions here.
What Is Post-Market Intelligence?
According to Bassil Akra, Ph.D., "What regulatory affairs professionals want... is a more sustainable way to achieve and maintain compliance."
Post-Market Intelligence (PMI) is a term coined by Huma.AI in the book "The Post-Market Gambit" to describe the multidisciplinary process of gathering, analyzing, synthesizing clinical, safety, and performance data to meet the EU MDR and IVDR regulatory compliance and post-market surveillance requirements. With an emphasis on a holistic approach to compliance, PMI focuses on the early identification of data and market signals that impact risk, performance, and competitiveness throughout the lifetime of medical devices and in-vitro diagnostics.
The new Post-Market Intelligence (PMI) platform from Huma.AI uses Machine Learning to streamline time-consuming workflows and ease the documentation burden on regulatory teams. To learn more about the Huma.AI PMI platform, including to request a demo, please request a discovery call today.