The pathway from ide to commercialization and maintenance of a medical device can sometimes be unclear and complex. Based on the regulatory strategi, the product(s) intended use, type of user, were to use hit, applicable standards and regulations this gives different type of requirements and activities that a legal manufacture needs to act upon during the lifetime of the medical device(s).

QAdvis is a solution-oriented service provider for the medical device and invitro diagnostic sector. Our team can together with established partnerships and international network provide a high level of knowhow to your projects. We understand your regulatory workflow and can quickly intergrate into you business and give the support you need.

Our areas of expertise are for example;

Clinical evaluation, performance evaluation and clinical evidence

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Read more about Clinical evaluation,
performance evaluation and clinical evidence here >>>

Biocompatibility

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More about our Biocompatibility area here >>>

Risk management, usability, cybersecurity

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usability, cybersecurity here >>>

Medical device software specialist services

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specialist services here >>>