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Linda Kellberg

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Specialist, Product and Process Compliance
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Recent Posts

Standard Compliance – a Must or a Myth?

Medical device regulations include requirements with which both the device and their manufacturer need to comply to enable legal market entry. However, these requirements are often vaque, described...

Top 10 benefits of applying appropriate Design Controls to your medical device development process

In short, Design Controls (or the practices of design and development as in ISO 13485) refers to the application of a set of formal quality practices and procedures to the conduct of product...


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