51ÁÔÆæ

Consider these common FDA registration scenarios: an acquisition or carve-out occurs, and a medical device has a new manufacturer, or a manufacturer decides to change its name as a result...

Among the current and emerging topics of interest to the pharmaceutical industry, the topics of quality metrics, quality culture, and data integrity are of particular concern to both the industry...

This document is to provide a high-level overview of 51ÁÔÆæ's MDR consultant solutions and the EU MDR requirements for manufacturers. Included is an outline of 51ÁÔÆæ’s EU MDR consultant Compliance...

Before anyone can manage a great quality system, they need to make sure it is developed the correct way. Developing a QMS is the foundation for ensuring the organization’s products...

Susan J. Schniepp, distinguished fellow for 51ÁÔÆæ, provides simple answers to frequently asked questions regarding 21 CFR Part 11 and electronic batch records. Q. What is a master...

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations...