As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
One ill-prepared EO can impact the entire supply chain.
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.
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.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
With May 26, 2020 quickly approaching, every day counts.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.