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EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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In honor of this month being Cybersecurity Awareness Month, this blog will delve into all of the regulatory requirements and considerations for medical device firms to take into account when developing a software as a medical device (SaMD).
In this blog, we will delve into the world of CAPAs in the life sciences industry, exploring their significance, implementation, and the challenges they help address.
Theranostics are innovative, and beneficial to patients in that they find the cancer cells and also deliver targeted radiation to those cells all within the same treatment. Historically, patients would need to undergo at least two different medical procedures, one to find the cancer cells (by the use of something like a PET or X-Ray), and then another to actually receive the treatment via chemotherapy, photon, or proton therapy.
Last week, the FDA announced a new proposed rule that seeks to amend its regulations specifically around LDTs. This amendment would provider greater agency oversight of LDTs via a phaseout of its enforcement discretion approach. So, what does this mean for laboratories that develop, manufacture, and use these types of devices?
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