For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
The wireless network serves as the backbone supporting patient care in every department of a healthcare facility. It is crucial to optimize and future-proof WiFi networks.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
A return to normalcy requires us to address the limits of current testing approaches and broadly deploy reliable screening tools that facilitate early detection and encourage more focused testing of those at high-risk of spreading the coronavirus.
A review of new, successful treatment options for the novel coronavirus.
The technology behind remote cardiac device monitoring is becoming more convenient, responsive and connected across the digital ecosystem—including a new smartphone app.
The absence of any of these disciplines can lead to blind spots that can introduce risk, but they are not all created equal.
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Adopting new technology to ensure the health and safety of patients shouldn’t adversely affect security and privacy.
Medical device security needs to address the cyber-physical threats, not just patient health information risk.