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)...
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...
The current regulatory environment has created opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on their products. On the one hand, the delayed EU Medical Device Regulation (MDR) deadline means manufacturers...
Have you ever wondered “why do labs ask for so much information?” Or “how can we speed up this testing process?” Those two questions actually have a lot to do with each other. The devil is in the detail. Labs need to ask a lot of questions about your device to be able...
If your organization is planning for a submission under the Medical Device Regulation (MDR), it’s important to consider outsourcing your testing needs to a testing lab. Working with an experienced partner that is well-versed in the latest standards can save you time,...
Every great chef has a secret “something” to their name – a recipe, a technique, an ingredient. It stands to reason that a lab largely concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn’t it? While some...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
