Medical device packaging validation helps ensure that a medical device cleared for commercialization will arrive to the end-user in an uncompromised, sterile state, and non-sterile product remains uncompromised during its journey to the user. Here are five important...
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...
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...
The Step-by-Step Guide to Creating a Life-Changing Class II Medical Device Navigating the Class II medical device development process can be overwhelming. With so much to do, how do you know where to start? We’ve outlined a step-by-step guide, allowing you to...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
