Description: Post-Market Surveillance (PMS) is not a new requirement of IVDR. However, what is new is the level of scrutiny and burden of evidence that IVDR Chapter VII and Annex VIII place on manufacturers to systematically gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire lifetime.
One of the most significant, long-term concerns manufacturers have about IVDR is having sufficient resources to digest everything they need to comply with the regulations.
For manufacturers that rely on manual processes, legacy technologies, and patchwork data systems, remaining in compliance in a systematic way will be increasingly difficult. Without automated tools that can easily monitor ALL of their relevant sources of evidence, including literature, registries, social media, complaints, and other market signals, manufacturers will face greater risk. AI solutions, including ML and NLP, offer great promise to eliminate data bottlenecks and transform regulatory workflows, and fulfill the true promise of PMS – driving innovation and increasing competitive advantage.
This session will discuss why many AI solutions fall short of their aspirational goals. In addition, the session will look at why the “intended purpose” of the AI itself is so crucial to creating sustainable PMS workflows. More importantly, why it is so important to find not just the right technology but also the right “technology partner” to help manufacturers to meet their regulatory needs and achieve their business goals.
The session will conclude with a live demonstration of how ML and NLP can help manufacturers develop a sustainable approach to IVDR Post-Market Compliance, including PER/CER and Risk Management.
Upon completion of this session, participants should be able to:
● Understand the proper role of technology in PMS compliance. ● Identify their company’s unmet/under met PMS needs. ● Envision what an ideal PMS solution looks like.