The European Union (EU) is strengthening safety and security at customs for its citizens through a large-scale cargo information system called Import Control System 2 (ICS2)...
Changes to medical device components may be prompted by several causes: supply chain issues, design changes, inter-device compatibility or component manufacturer changes...
ISO/TS 23565 addresses an unmet need in the specification of cell processing systems. It describes the minimum requirements for the equipment, software and consumables used in the manufacturing and processing of cells for therapeutic use...
Regulatory, compliance and quality management system considerations may vary between medical devices, components and accessories. Understanding these differences helps organizations to better identify their roles and responsibilities related to sales...
Mechanical hose barb connections consist of a hose barb, flexible tubing and a retention device. Retention devices are generally placed closely behind the barb and are used to improve the connection’s pull-off strength and pressure resistance...
FDA regulation of health products must adapt to new and emerging technologies. This update reviews product classification for cell and gene therapy to help aid better-informed informed decisions on product development and planning.
Ensuring adequate supply chain of components used in medical devices and for the manufacture of drugs and biologics is more challenging and more critical than ever. Find out what steps you can take to reduce the risk of component shortages and their consequences.
Connectors are used in many types of medical and diagnostic devices. Learn strategies for development and testing connections to help reduce verification and validation burden, mitigate the risks associated with misconnections and supply interruptions, and ensure predicable performance for these connections...
Process monitoring and control of critical process parameters are required to ensure product quality. The most common methods for process monitoring are linked to sampling...
Nylon is used in the manufacture of many single-use components for medical device and bioprocessing applications. With surging customer demand, lead times for nylon have extended beyond explanation, causing significant disruptions in the global supply chain and unprecedented shortages...
Ionizing irradiation, typically gamma, has been the most used method of sterilization and bioburden control for single-use bioprocess systems for more than 20 years. Still, there remains some confusion around the need for sterile or bioburden-controlled systems and how to achieve it...
Gamma irradiation is a key technology for the sterilization and bioburden control of medical devices and single-use bioprocess systems...
This blog outlines five key benefits of genderless aseptic connectors and how they can lead to more flexibility, reduced risk and lower costs for your organization.
The global supply chains for many raw materials and finished goods are experiencing unprecedented shortages and supply interruptions, in particular, the supply of plastic resins...
Mechanical hose barb connections, which consist of the hose barb, tubing and retention device, are ubiquitous in single-use systems (SuS). They look deceptively simple, but the process of bringing all three elements...
