Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
A timely step toward ensuring patient safety through data-driven product development.
The technology can prevent ongoing tissue damage and degeneration before an issue becomes too large to fix.
Integrity is what matters most, and it just makes good business sense.
Going paperless is easier than you think.
In addition, in workforce optimization, retention plays an equally important role as recruitment.
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
Infusion pump companies are perpetuating misconceptions.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
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.