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

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...

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 ...

Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure integrity. When assuring the quality of all packaged products, testing ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

At the end of 2019, the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany, bringing more ...

The evaluation of biological safety is one important piece of the puzzle to demonstrate the safety of a medical device. Commonly, manufacturers make use of the ISO 10993 series of standards to assess ...

On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...