Designing the Worst-Case Test to Get Best Case Results
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Tag Archives: instructions for use
EU MDR 101: Preparing Technical Documentation
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Medical Device Cybersecurity in the Age of IoMT
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
Electronic Product Information: A Roadmap to the Business Benefits
Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators. But many firms in the medtech sector are not maximizing the opportunity to deliver regulated product information digitally.
Device Manufacturers Should Modernize IFU’s for Reliable, Automated, Point-of-Care Device Disinfection
COVID-19 requires us to rethink our current device disinfection procedure.
How to Get More Mileage Out of Your Electronic IFU
Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.
Preventing Contaminated Medical Devices in the Context of COVID-19
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
EU MDR: Will You Be Able to Sell Your Medical Device in Europe after May 26?
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
New App Alerts Patients and Caregivers to Medical Device Recalls
By simply scanning a barcode, SoomSafety gives users access to important product instructions, safety and recall information.
Now You’re Speaking My Language: Modernizing Instructions for Use to Comply with MDR
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
