Combination products—as the name suggests—represent a mixture of medical products. They comprise any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. The variety...
Regulatory
Why Complete Chemical Characterization Matters for Plastics
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...
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...
Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know
Sterilization validation is necessary to bring tissue-based products to market. The U.S. FDA requires it, whether the device functions in vivo or in vitro, so understanding how to ensure sterility is critical. When it comes to living tissue, the process carries an...
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...
The Critical Role Reprocessing Instructions Play in a Medical Device’s IFUs
Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed, action-oriented instructions on preparing, administering, handling, storing and disposing of the device. When...
Are You Prepared If Your Disinfectant Is Discontinued?
The U.S. EPA banned the active ingredient in a popular disinfectant in 2018. Would you know what to do if your go-to cleaning product was phased out?
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.