Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating ...

Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. Send the instructions for use (IFU), labeling, protocol, investigator brochure, or ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

Standard extraction and biocompatibility workflows were not built with tissue-derived products, hydrogels, absorbables, or silicone implants in mind. Apply them without modification and the failures ...

Developing next-generation digital droplet technologies demands exceptional manufacturing precision, rapid design refinement, and scalable production methods. This customer success story highlights ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

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 ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...

ISO technical committee (ISO/TC) 194, Biological and clinical evaluation of medical devices, subcommittee (SC) 1, Tissue product safety, in collaboration with the European Committee for ...

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 — ...