Device Labeling: Best Practices
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
Tag Archives: regulations
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.
Asia 2020 Device Regulatory Update
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
How COVID-19 May Be the Catalyst in Ensuring a Healthy Future for Telemedicine
With everything to gain, telehealth may lead to a new standard in health/wellness treatment while at the same time unifying the entire healthcare ecosystem.
Great Medical Devices Require High-Functioning Supply Chains
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
How Are Medical Device Companies Addressing EU MDR?
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
Regulatory Reporting: What can Medical Device Manufacturers Learn from Big Pharma?
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
IVDR signals In Vitro Industry Shake-up
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
EU Device Regulations – What’s Changing and What Will Be The Impact?
What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.
What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.
