Nanna Finne
Senior Regulatory Affairs Specialist, Scilife
Nanna has a proven track record of guiding medical device companies through the complexities of compliance across major markets. With an affinity for clinical evaluations, post-market surveillance, and process optimization, she continues her passion for ensuring quality products reach patients and end users. Not one to miss the smaller details, she encourages continuous improvements in everything she does.
Ah, design verification—the unsung hero of medical device development. It’s the phase where we ask, “Did we build this thing right?” before moving on to validation, which asks, “Did we build the right thing?”
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.
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...
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