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

Harnessing AI for Regulatory Compliance

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 compliance. 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.

Make Sure You’re EU IVDR Compliant

The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.

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 systematic 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 approvals, and redefine healthcare communication,” stated Sonia Veluchamy, CEO of Celegence.

Sonia Veluchamy - CEO 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 - Celegence

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.

To see how we can help you with your regulatory compliance just contact us online now and a member of our team will get back to you shortly.