This course will give you a comprehensive walk-through of the regulatory requirements on development of medical devices. We discuss practical aspects related to the requirements and how development can be done in an effective way that also supports a safe and suitable product when on the market.
Individuals working with product and process development, product maintenance and Quality Assurance/Regulatory Affairs that needs comprehensive knowledge within the area. Also individuals working with internal or supplier audits will benefit from the content.
You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
You should have at least 6-12 months experience of working with development and/or manufacturing of Medical Device products.
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