Full Circle Consulting

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.

Full Service

Full Circle Consulting

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Quality System Development

Quality System Implementation

Post Market Compliance

ISO Standards Consulting


Product Development

Manufacturing & Distribution


Regulatory Strategy

Regulatory Submissions


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Project Management

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Full Circle Consulting Resources

Cybersecurity in Medical Devices

Cybersecurity in Medical Devices

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).
Innovating Healthcare: Theranostics

Innovating Healthcare: Theranostics

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.
The FDA and Lab Developed Tests

The FDA and Lab Developed Tests

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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