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 ...

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

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 ...

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 ...

ArQ ® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container ...

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

Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and ...

Navigating the evolving landscape of global regulations concerning Per- and Polyfluoroalkyl Substances (PFAS) in medical devices requires a proactive, comprehensive strategy. Manufacturers must ...

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

The transformation of medical technologies into connected devices has dramatically expanded how health data is collected and used, introducing new responsibilities for manufacturers in safeguarding ...