The objective of the course is to create a basic understanding for the regulatory and quality framework surrounding a Medical device or an In-Vitro Diagnostic device in USA.
The course will cover main topics in the Quality System Regulation, recognized standards, design control and risk management of a medical device.
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Training course / seminars
This course can be modified to reflect your product and company. It can be held at customer site or online.
Price depends on the overall arrangement for your customized course. An offer will be submitted based on your request.
More about our customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
