To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
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.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
COVID-19 requires us to rethink our current device disinfection procedure.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.