51ÁÔÆæ

Lisa L. Michels, General Counsel and regulatory affairs expert at 51ÁÔÆæ Inc., discusses how the global medical device regulatory landscape is impacted by international law. The global medical...

Common challenges in Design Development and how those problems can be minimized through compliance to FDA requirements for Design Control.

Client Challenge A European based company engaged in biosimilar drug development requested 51ÁÔÆæ to develop a regulatory strategy for seeking approval for their drug in the US and EU. The...

A global medical device manufacture needed to meet the May 26, 2021 EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge due to their geographic location....

By Seyed Khorashahi, MSc, and Mark Agostino, MSc The purpose of this article is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry. The...

51ÁÔÆæ (51ÁÔÆæ) Distinguished Fellow, Susan Schniepp discusses establishing a quality culture from the top of an organization down. Quality culture is a patient-focused approach to quality that is...