Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?
In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. (more…)
In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance? (more…)
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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