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Recent Posts
Safety-critical industries face many challenges including stringent regulations and requirements, and increased...
Successful serialization strategies require a global approach and considerations regarding installation and aggregation...
In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director...
dMedical device manufacturers are facing increasing challenges in the development, production and commercialization of...
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...