Nanna Finne

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers.

Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...

The prime directive of medical device manufacturers is the continued safety of patients through safe and effective medical devices. A critical aspect of medical device safety is ensuring regulatory compliance of any medical device destined for the co...

Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...

GMP stands for “good manufacturing practices.” Life sciences companies need to be GMP-certified in order to produce and sell their products. But what do GMP guidelines entail? And how is GMP different from cGMP, or “current good manufacturing practic...