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 ...

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 ...

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of ...

Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal ...

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink ...

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 ...

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure ...

The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

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 — ...