Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
A lot of promises are made by organizations about making systems more intuitive, convenient and user-centric, but in reality most improvements tend to be designed to meet regulatory or internal system needs rather than better serve the people who use them. The user experience needs to be modernized, especially in heavily regulated industries where inaccurate or non-compliant labeling is laden with risk.
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.
Both paper and digital paper are outdated approaches to medical device quality management.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
Going paperless is easier than you think.
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
When it comes to adverse event reporting, the FDA does not grant exemptions.