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: MDR
Playing by the Rules: A Lever for Doing Better Business?
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
Capitalizing on Standardized International Product Data
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
2020 Business Outlook: Five Macrotrends Changing the Way Medtech Does Business
A discussion of the changing medtech markets and how companies can remain cognizant of potentially disruptive changes in their business and industry for future success in their product portfolios, services and relationships.
Will the 2020 Elections Affect MedTech Investment? Maybe
The outlook for 2020 and beyond is positive, but medical device companies must continue to evolve their technologies and partnerships to keep the attention of investors.
FDA’s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
New MDR: One Year into the Transition Period
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Five Most Popular Articles of 2018 (So Far)
Here’s a hint: Compliance with new regulation in Europe is a high priority.
Understanding FDA’s Guidance on Medical Device Reporting
How in touch are you with current MDR guidelines?
The New MDR: Opportunity Knocks
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
