Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...

Medical device rapid prototyping cuts development delays by 40% despite talent shortages. Achieve ISO 13485 compliance and faster iteration cycles. The medical device industry is navigating a perfect ...