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.
ISO 13485 audits can intimidate anyone. It sounds rigid and technical, and like it is designed to catch you out. This is why in this article we will walk you through how to prepare for an ISO 13485 audit, without the stress.
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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