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Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Attend this webinar to learn about when you require a premarket approval for a medical device and FDA approval process for medical devices.

Attend this webinar to learn do's & don'ts of medical device design process and also methods with which a company can capture most of the requirements.

"This report provides detailed historical analysis of global market for Intravenous Sets from 2013-2018, and provides extensive market forecasts from 2018-2028 by region/country and subsectors. It covers the sales volume, price, revenue, gross margin, historical growth and future perspectives in the Intravenous Sets market. Leading players of Intravenous Sets including: * B. Braun * CareFusion (Becton Dickinson) * Fresenius Kabi * Codan * Hospira * Baxter International * Vygon * Smiths Medical * ICU Medical"

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.