The Elephant in the Room: RAPS LIVE Discussion on Developing a Sustainable Approach to IVDR Post-Market Compliance

By Sean Smith on April, 8 2022

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Huma.AI Co-Founder Lana Feng, Ph.D., to Present at RAPS Convergence 2022

Huma.AI is pleased to announce that Lana Feng, Ph.D. CEO and Co-Founder of Huma.AI will be speaking live, in person at RAPS Convergence 2022, to be held between 11-13 September in Phoenix, Arizona.  

The percentage of in vitro devices that will require notified body certification is estimated to go from less than 15% under the IVDD to as much as 90% under the IVDR. 

While extensive guidance for MDR has been shared with manufacturers, the same cannot yet be said for IVDR. This limited guidance has left manufacturers with insufficient information to move forward. Confusion is commonplace, and regulatory professionals are increasingly seeking innovative approaches to tackle their data challenges. This has become an ‘elephant in the room’ for IVD manufacturers.


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Machine Learning Is The Solution

“For manufacturers that still rely mainly on manual processes, legacy technologies, and patchwork data systems, remaining in compliance with regulatory expectations in a systematic way is a practical impossibility,” declared Dr. Feng.

“Machine learning offers great promise to eliminate data bottlenecks and transform regulatory workflows, thereby maximizing their time, talent, and tools.” 

The talent required to gather, record, and analyze relevant data is in short supply, thus creating a demand for innovative solutions that can ease the transition to IVDR compliance. With Machine Learning (ML) and Natural Language Processing (NLP), manufacturers can develop a sustainable approach to IVDR, facilitating reporting required for Post-Market Surveillance, Performance Evaluation, and Clinical Evidence. 

Regulatory Affairs professionals interested in learning more about applying Machine Learning to IVDR compliance should be sure to attend Dr. Feng’s presentation at RAPS Convergence 2022, 11-13 September in Phoenix, Arizona. 

After the session, participants will be able to:

  • Understand the proper role of technology in building a more sustainable PMS compliance workflow (ML technology doesn’t want your job; it wants to make your job more manageable).
  • Describe how “transparent” ML technology not only accelerates the most time-consuming and unscalable aspects of the regulatory process but also fosters innovation company-wide.
  • Explain why sustainable PMS success depends on having the right tools, carpenter, and architect.

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A Technology Partner with Deep Life Science Experience

Dr. Feng’s decades of experience in the life science industry make Huma.AI an ideal technology partner for companies that are exploring alternative ways to address mounting data challenges specific to MedTech. Huma.AI offers solutions that accelerate IVDR compliance workflows, empower regulatory professionals, and drive innovation. 

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To learn more about streamlining your IVDR compliance processes, request a discovery call and demo below.

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