Aug 4
FDA Breakthrough Devices Program Update and Advantages
The FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015. The program is gaining popularity with 11 designations in 2016, 19 in 2017, 55 in 2018 and 50 designations as of May 2020.
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Our experience submitting under the Health Canada Interim Order
Reference designs for medical device development are a great way to ramp up a project faster and more cost effectively. At work, we’ve adopted a strategy of developing our own reference designs of subsystems that we believe will be useful in future projects.
This article is about the parasitic properties of capacitors. It discusses the issues they cause, mitigating the parasitic properties, and even how to turn them into something useful.
This blog shares how to identify which medical device standards apply to the device you’re bringing to market and provides an overview of major standards at various regulatory levels for novices.
Make a real-time, wavelength-calibrated spectrometer using common household items.
What makes smartphones as a medical device exciting as potential point of care platform?
Real medical devices from the imagination of science fiction