AI-Powered Solutions for Regulatory Excellence in the Medical Device Industry

In the fast-evolving landscape of the medical device industry, harnessing the power of Artificial Intelligence (AI) is not just advantageous but essential for maintaining regulatory excellence. At Celegence, we recognized the potential of AI to streamline complex processes and enhance efficiency in areas such as writing Clinical Evaluation Reports for Medical Devices.
The Power of AI-Assisted Regulatory Writing
Our journey began with a clear objective: to optimize regulatory processes using AI while leveraging our regulatory expertise. By combining AI capabilities with our deep understanding of regulatory requirements, we developed prompt-based interactions that streamline data extraction during literature reviews for Clinical Evaluation Reports.
For instance, our AI-powered platform, CAPTIS, facilitates effortless extraction of essential data points such as study objectives, types, participant numbers, and follow-up durations.
"With contextual prompts tailored to specific requirements, writers can ensure consistency and accuracy in data presentation, thereby reducing manual errors and enhancing efficiency saving countless hours of manual review. As we harness the power of AI power, we elevate patient safety, accelerate drug approvals, and redefine healthcare communication," stated Sonia Veluchamy, CEO of Celegence.
AI Works Even Better with Instructions!
The beauty of AI is its ability to learn and adapt. The more specific your prompts, the better the results. For example, a writer can set up a prompt to automatically format participant age data in a consistent way across all reviewed studies. This eliminates the risk of inconsistencies and saves time and effort.
Merging AI and Regulatory Expertise
While AI excels at extraction, its true potential is unlocked when combined with deep regulatory knowledge. This synergy allows companies to navigate complex regulatory landscapes like Clinical Evaluations and Post-Market Clinical Follow-ups with greater agility and precision.
Here's a powerful example: imagine an AI tool that generates the initial framework for your State-of-the-Art Section in a clinical evaluation report. This AI assistant, guided by regulations like EU MDR and MEDDEV Rev 4, can provide information on clinical background, including epidemiology, treatment objectives, and the rationale for using your specific device. It can also give you information on the available alternative treatment options, and device-relevant safety and performance indicators. This foundational information can help medical writers overcome initial obstacles, and get straight to crafting a compelling narrative.
Celegence: Your Partner in AI-Powered Regulatory Excellence
At Celegence, we have extensive experience developing technology solutions for the medical device and pharma industry. We understand the challenges you face and the transformative power of automation and AI. Our team of experts combines cutting-edge technology with a deep understanding of regulatory frameworks.
We offer a range of solutions, from AI-powered platforms to niche regulatory software. Our goal is to empower companies to achieve excellence in their medical device or pharmaceutical regulatory pathways, paving the way for safer and more effective medical devices that ultimately improve patient outcomes worldwide.

Celegence LLC 1213 Butterfield Road, Downers Grove, IL 60515

Sonia Veluchamy is the CEO and co-founder of Celegence, a company dedicated to improving patient outcomes through intelligent regulatory compliance. With extensive regulatory expertise that spans all types of products, Celegence has gained rapid recognition, counting two top 5 pharmaceutical companies and several top 20 medical device companies among its esteemed clients. Through optimizing teams with tech-enabled services, Celegence supports these clients in navigating regulatory challenges, achieving compliance with evolving regulations, and reducing time to market in the most time and cost-efficient way.

This release was published on openPR.