Medical device developers are constantly looking for regulatory changes that may impact how they work. Sometimes minor changes in regulation can make their lives a lot easier, while alterations add extra steps to a process elsewhere. Changes to ISO 10993-17 have been...
High-resolution quadrupole time-of-flight (QTOF) gas chromatography–mass spectrometry (GC-QTOF-MS) provides a powerful combination of high mass accuracy with trace level detection capabilities. Applying the technique to extractables and leachables testing (E&L)...
As regulatory guidance evolves, a new expectation around preclinical medical device safety testing is emerging: Unknown chemicals are unacceptable. The new risk-based approach means regulatory bodies expect complete chemical characterization. Testing can include all...
When it comes to medical devices, regulatory standards are never set in stone. The guidance offered by authorities is ever evolving, as technology advances, new data becomes available and old interpretations become obsolete. As medical device manufacturers innovate,...
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...
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...
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...
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...
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...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
