On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and machine learning expands throughout industry and online.
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
AI can support device innovation and surgical training, but it requires data and collaboration.
Ultrasound technology has gone through a massive, recent progression. This article reviews four trends defining these enhancements.
MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.
Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.
Data, IoT, artificial intelligence, predictive analytics, virtual and augmented reality, and many other technologies will fuel the healthcare system.
