What is a CEC? In clinical trials that include a high-risk patient demographic, a clinical events committee...
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
The In Vitro Diagnostic Directive (EU) 98/79/EC (IVDD) was introduced over two decades ago to establish the...
An update to our blog about how digital health technology is optimizing the clinical research industry. Introduction...
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party...
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
During the summer of 2022, we expanded into a new space to better serve our customers. This...
The new version of ISO 10993-17 is expected to be published very soon. This is a major...
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