FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

<p data-end="215" data-start="0">Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept ...

Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization ...

Biocompatibility assessment per ISO 10993 ensures medical device safety by evaluating materials, risks, and biological effects, emphasizing rigorous risk management, updated standards, and reduced ...

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore&nbsp;the suitability of needle-free polycarbonate&nbsp;transfer devices.