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Recent Posts
Medical device developers have a series of hurdles they need to navigate in order to successfully bring their device to...
In today’s post we draw on the expertise and insights of EngiSystems to examine the growing impact of recalls in the...
At the American Biomanufacturing Summit last May we had the opportunity to sit down with one of our key speakers,...
Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of...
“When granting regulatory approvals for medical devices, both IEC 62366 and the FDA have emphasized the importance of...
eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care
Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations...
In today’s infographic we take a closer look at the guiding principles of a quality management system (QMS). The goal...
Operational excellence is a key area of focus at the American Biomanufacturing Summit taking place on May 10-11 in San...
We were thrilled that Robert Sparadoski, Associate Vice President, Quality Assurance at Ferring Pharmaceuticals could...
There are many changes on the horizon for the life sciences industry. To help pharmaceutical manufacturers navigate the...