Regulatory and Related Activities through the Device Lifecycle
Course Info
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Course Details
Introduction
Objective
Who should attend
Course Location
The size of the medical device market has expanded over recent years and this trend is forecast to continue.
This course is designed for regulatory affairs professionals to develop and deepen their understanding of a variety of topics of importance to the maintenance of the commercial and regulatory health of their company's medical devices once they have been successfully placed on the market.
Topics include advertising, data protection and privacy, patents and IP, health technology assessment and reimbursement, environmental legislation and standards, relationships with distributors, own-branders, authorised representatives, trade association and regulatory bodies, product supply and logistics, product liability law, unannounced audits and good regulatory practice.
Course Outline
The medical device markets
- Markets and Culture
- Healthcare
- Business culture