This article highlights what manufacturers should prioritize and areas in which new information may still emerge, along with providing a starting point for businesses that need to familiarize themselves with the UK Conformity Assessed marking requirements.
EMA’s IDMP is not the pinnacle of data-based product/regulatory information management. It is simply the first in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. This article reviews best practices for companies looking to maximize the ROI of their data-driven process transformation initiatives by making them more broadly fit for the future.
Due to rapidly evolving regulatory landscape and manufacturing demands, label requirements and the information they contain are constantly changing. Here’s how medtech organizations can manage the process.
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.
Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.
In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
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.
Moving too quickly in the product development process can lead to mistakes.