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Regulatory teams face increasing pressure to be agile, simultaneously managing submissions of varying size and complexity while meeting evolving global health authority (requirements. However, siloed systems often hinder visibility into submission data and progress.

Bringing publishing in-house can reduce submission timelines by as much as 50%. To reap the benefits of continuous publishing, regulatory teams need a clear plan to effectively support end users and ease the change management burden.

Real-world evidence (RWE) can enhance our understanding of the safety, performance, and effectiveness of medical technologies, and health authorities are increasingly recognizing its benefits in informing regulatory decisions across the product lifecycle.

To be effective, AI must be applied precisely to purpose and guided by human expertise. In this article, we'll discuss how life sciences companies and the patients they serve can benefit from this transformative technology.

Continuous publishing allows for the simultaneous and iterative completion of traditional downstream publishing tasks alongside traditional upstream planning and authoring tasks. This speeds and streamlines the entire submission preparation process and encourages more focus on the quality of submissions.

Today, there is an intentional shift underway to uplift the patient voice and encourage the pharmaceutical and medtech industry to more closely partner with patients to advance safety science innovation to improve health outcomes.

Biopharma companies are accelerating submission timelines with a continuous publishing approach. Learn how they proactively mitigate risk and address issues earlier in the submission cycle so that publishers can review, analyze, and submit a quality application without teams working inefficiently or overtime.

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements. Medical device software is bound by regulatory requirements and constraints to ensure the medical devices will not harm patients. Bringing medical device software, hardware, and mobile medical device apps to market requires successful navigation of the EU CE Marking and US Food and Drug Administration (FDA) approval processes.

SSPs benefit both patients and healthcare professionals. Because they are publicly available, patients can use SSPs to research IVDs recommended by healthcare professionals to learn more about the devices. Healthcare professionals can also use SSPs to better understand the performance data that has been used to support CE marking of the devices.

Managing regulatory activities creates several challenges: struggling with poor data quality, duplication, and limited visibility because of disjointed processes. Add in new regulations like EU MDR and IVDR and the complexity is compounded.

Learn how the introduction of a cloud-based regulatory information management (RIM) solution can help a team operate faster, while ensuring compliance.

As the volume of information continues to increase in the age of information overload, medtech companies face compliance risks in continuing to operate with manual and/or siloed systems that could disrupt their ability to effectively deliver compliant commercial content.