Not all plastics are created equal. Plastic and polymeric products, parts and components can include significant numbers of chemical constituents—so it is important to understand how a filter, bag, container, delivery system or implantable device will react while in...
Medical Device
Marketing Medical Devices in the U.S. | WuXi AppTec
The most rewarding part of the job for medical device manufacturers is seeing the result of their hard work making a real difference in patients’ lives. But getting an effective, innovative, and safe product to market in the U.S. and the European Union (EU) means...
ISO 10993-18 Primer: Medical Device Chemical Characterization
Complete chemical characterization is critical for not only the submission of your medical device but also – and most importantly – patient safety. This primer covers the most important things you need to know about performing a complete chemical characterization...
ISO 10993-1 Primer: Medical Device Testing for Risk Management
Planning a biological evaluation of your medical device? Then you need to be familiar with ISO 10993-1. This primer covers the fundamentals. The International Organization for Standardization (ISO) develops and publishes a wide range of proprietary, industrial and...
Class II Medical Device Verification and Validation: What Goes into it?
Understanding Medical Device Verification and Validation When it comes to ensuring the safety and efficacy of medical devices, rigorous processes are in place to verify and validate their performance. This blog will delve into the world of Class II medical devices,...
Medical Device Industry Trends to Watch
Medical Device Industry Trends for 2024 and Beyond The medical device industry is constantly evolving, driven by advancements in technology, changing healthcare needs, and a growing focus on patient-centric care. As we look ahead to 2024 and beyond, several key trends...
What to Look for in Medical Device Component Manufacturers
Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation. Whether it’s a life-saving implant, a diagnostic instrument, or a sophisticated monitoring device, the quality...
What is the Class II Medical Device Design and Development Process?
Innovation plays a pivotal role in enhancing patient care, diagnostics, and treatment outcomes. One critical aspect of this innovation is the design and development of Class II medical devices. This process involves a variety of stages, ensuring the final product...
Benefits of Class II Medical Device Contract Manufacturing
Partnering with a Class II Medical Device Manufacturing Company Saves Time and Money Class II medical device manufacturing requires precision, compliance, and efficiency. Today, companies must meet increasing market demands while maintaining high-quality...
Understanding Medical Device Conceptualization and Research
A Guide to Medical Device Conceptualization and Research Do you have an idea for a Class II medical device, but you’re not sure where to start? You’re not alone. Many individuals and small organizations have life-changing ideas, but may not see their ideas to fruition...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.