Information for today’s Regulatory Professional
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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Can you identify your critical suppliers, link each to their respective product codes and registration status? Many medical device regulatory affairs teams struggle to connect these dots.
The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.
We are excited to be sponsoring the upcoming FDANews webcast titled Sustained Medical Device Regulation Compliance: Ensure Your Regulatory Processes and Tools are Fully Optimized. Join us on May 20th at 1:30 PM US EST to understand how to optimize your processes and tools to ensure that your regulatory operations can help get new products […]
Everyone, especially senior regulatory executives, has a preference for communication styles. Does your line manager request a departmental update via a one-hour presentation with lots of colourful graphics, an email composed of <200 words or a 10-minute telephone call? Regulatory professionals spend enough time justifying their role without supplementing any negative perception by presenting information to key stakeholders utilising the wrong approach……
Attention all manufacturers. Are you aware that if an Economic Operator (EO) considers your medical device to not be in conformity with MDR requirements, they are obligated to inform the competent authorities, thus impeding progress of your supply chain channels? The European medical device regulation places more direct responsibility on individual entities in the medical […]