Criterion Edge provides medical and regulatory writing services for the medical device, pharmaceutical, and in vitro diagnostics industries and will be attending RAPS Euro Convergence in Amsterdam, from May 10-12. Our specialists will be on site at the conference ready to meet you and your team to discuss your writing or project needs. Stop by our booth for a chance to win a cool travel accessory each day.
You can register here if you haven’t already. Explore the full 2022 convergence agenda here.
Criterion Edge supports medical device companies like the ones attending with the production of the required MDR submissions. These include, but are not limited to, clinical evaluations reports (CER) and plans (CEP), clinical performance reports (CPR), post-market clinical follow-up (PMCF) plans and reports, post-market surveillance (PMS) reports, PSURs and summary of safety and clinical performance (SSCP), and systematic literature reviews. Read more about us here.
If you’re attending, let’s schedule time to meet in person at the event. If you can’t make it to the conference, we’d still like to meet and chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
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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