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Navigating International Standards and Regulations for Medical Devices – A Presentation on ISO standards, the FDA and the European Medical Device Directive
Engineering organizations building medical device products, must overcome critical business challenges related to meeting or exceeding quality standards while navigating the ever increasing level of regulation by bodies like the European Union and the FDA. This compliance burden and navigating the complexities of the various ISO standards threatens an organization’s ability to meet time to market goals and thus, can have a dramatic affect on company revenues.
This On-Demand Webinar will help you learn how medical device organizations can more effectively conform to global standards while actually accelerating development cycles. The session will include a brief overview of the primary global standards and their impact on product development, with a focus on how the complex challenges of software engineering organizations can be overcome through process automation, traceability and reuse throughout the development lifecycle.