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The only constant today is change itself.
Tag Archives: EU MDR
In Search of Flawless Devices
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
Artificial Intelligence Boosts New Era of Postmarket Intelligence
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
Countdown to June 2023 for UKCA compliance
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.
Smart IDMP: How to Ensure Preparations for ‘Data-Driven’ Future Are a One-Time Investment
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.
Addressing Hidden Risks in Medical Device Labeling Operations
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.
EU MDR Compliance: Do Your CERs and PERs Hit the Regulatory Bar?
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.
Cybersecurity by Design in Medical Devices
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.
Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?
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.
