During product development, collaboration between software, hardware and quality teams must be tracked and seamless to meet the increasing pace of market demand.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
While connected capabilities and wireless technology certainly lead to greater patient care, they also expose devices to greater cybersecurity risks.
This year’s virtual event features experts from medical device companies, hospitals and government organizations.
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.
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Both paper and digital paper are outdated approaches to medical device quality management.