Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
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.