What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Tag Archives: regulatory
Compliance Is Compulsory, and Product Labeling Is No Exception
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
Considering CAPA: Maybe It’s Not a Monster After All
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
The Top Trend for Medical Devices in 2021? Putting Quality First
Moving too quickly in the product development process can lead to mistakes.
The Future of MedTech and Healthcare: No Boundary on Uniting Forces
All industries under the healthcare umbrella should embrace each other’s capabilities because no single category of player can master it and bring to consumers all that we need and demand, says Stephen Bernstein of McDermott Will & Emery.
Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
An Intelligent Approach to Modernizing Quality Management Systems
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
Patent and Regulatory Challenges in AI’s Use in Life Sciences
With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries.
Medical Device Cybersecurity Conference to Tackle Critical Legacy Issues
This year’s virtual event features experts from medical device companies, hospitals and government organizations.
