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How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers
Medical device developers are constantly looking for regulatory changes that may impact how they work. Sometimes minor changes in regulation can make their...
Using High Resolution Gas Chromatography to Keep Costs in Control While also Protecting Patients
High-resolution quadrupole time-of-flight (QTOF) gas chromatography–mass spectrometry (GC-QTOF-MS) provides a powerful combination of high mass accuracy with...
Case Studies: Evolving Regulatory Trends Require Trusted Lab Testing Partners
As regulatory guidance evolves, a new expectation around preclinical medical device safety testing is emerging: Unknown chemicals are unacceptable. The new...
How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment
When it comes to medical devices, regulatory standards are never set in stone. The guidance offered by authorities is ever evolving, as technology advances,...
Understanding the Complex Combination Product Pathway
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...
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...
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...
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...
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...
Navigating European Medical Device Premarket Submissions
Navigating the tricky waters of regulation can be frustrating and challenging for any medical device manufacturer. When those regulations change, the prospect...
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...
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,...