11.07.23 -- Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance

Automated manufacturing is a powerful but often-misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Here, we delve deeper into the CCI testing of biologics and effective test methods.

Explore the progress of the new European Union Medical Device Regulation and the In Vitro Device Regulation, and how the lack of notified bodies could affect timely implementation.

When discussing partnerships with OEMs, we often refer to our robust quality management system (QMS). It sounds great, but what does this mean for you, and what does it mean for us?

RFID is increasingly being used in medical devices. Explore guidance on finding a suitable RFID partner, including what to look for in a supplier, case studies, and proprietary technologies.