Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of ...

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based ...

Per- and polyfluoroalkyl substances (PFAS), widely used in medical devices for their durability, biocompatibility, and resistance to temperature and moisture, are under growing scrutiny. Known as ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...

On Dec. 8, 2021, CEN, the European standards body, released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This edition, ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

A common dilemma for early stage medical device companies is their lack of expertise in medical device development. As expected, the development team is busy establishing the company itself while ...