This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...

This article discusses the challenges and opportunities within the digital health technology postmarketing safety and surveillance arena faced by many manufactures. The authors discuss the opportunities and challenges these devices and technologies may present, compared to the traditional healthcare products in the regulated arena.   Introduction   The term digital health solution is used to categorize technology available through a multitude of devices which provi...