Anyone who has been doing risk management for medical devices or combination products is familiar with the ISO 14971:2019 and ISO/TR 24971:2020 standards. These recognized standards describe a risk ...
The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage ...
Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure ...
Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of ...
Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and ...
Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink ...
Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal ...
Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad ...
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 — ...
Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...
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 ...
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