Harmonization Archives

Why Perform a Gap Analysis?

‌ As new technologies continuously push the limits of medical devices and drugs, regulations and governing...

‌ Becton, Dickinson, and Company, or BD, announced on August 27, that the US Food and Drug Administration (FDA)...

‌ This past Monday, the FDA announced fiscal year (FY) 2022 medical device user fees. This upcoming fiscal year...

‌ The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...

$X-Ray Diffraction, a Useful Characterization Technique$

‌ X-ray diffraction (XRD) is a non-destructive laboratory technique that assesses the lattice spacing of crystalline...

Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...

For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...

The EU Commission released a new guidance document clarifying the purpose of harmonized standards under the EU Medical...

FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into...

Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the...