Celegence CEO Sonia Veluchamy Interview in Empowered Patient Podcast

Sonia Veluchamy, CEO and Co-Founder of Celegence, sits down with Karen Jagoda of the Empowered Patient Podcast to share insights on the escalating regulatory demands and complexities facing the medical device industry and how they can effectively thrive. Celegence supports companies in enhancing their regulatory data management and adopting advanced technology solutions to handle compliance more efficiently.

“If medical device companies can prioritize process and data governance and invest in the right tools and processes upfront to establish strong data management and governance frameworks, this will help them manage compliance more efficiently and avoid some of this costly remediation down the line. Coupled with strategic partnerships, we talked about having not just a technology vendor but a partner who also understands the regulatory landscape and its intricacies. This is going to be crucial for companies to be successful in this journey.” 

– Sonia Veluchamy, CEO & Co-Founder of Celegence

The podcast discussion focuses on:

1. Increasing Regulatory Demands: Medical device companies are now facing stringent regulations like the EU MDR, which requires ongoing, detailed documentation for compliance. These companies have been slower than pharmaceuticals in adopting regulatory tech, partly due to slower changes in device regulations.
2. Importance of Centralized Data Management: Sonia emphasizes a proactive approach to regulatory data management and governance, using advanced tech for real-time tracking of compliance activities. Streamlined, lean processes can reduce costs, improve documentation quality, and help avoid delays in product approvals.
3. Opportunities with Technology: The integration of AI and software in medical devices presents both challenges and opportunities. While it adds complexity to compliance, it also enables innovation and opens global market opportunities. Successfully proving the safety and efficacy of these advanced devices is crucial for regulatory approval and market access.
4. Leveraging Partnerships and Expertise: Partnering with experts who understand regulations can further aid navigation through the complex landscape such as AI-enabled expertise. A survey Celegence conducted with RAPS reveals that resource limitations are a major challenge for medical device companies. Many lack specialized regulatory expertise, underscoring the need for tech solutions and knowledgeable partners.
5. Focus on Efficiency and Quality: Streamlining data management processes and utilizing technology improves efficiency in regulatory compliance. Automation can contribute to consistent, high-quality documentation that meets regulatory requirements in a more streamlined way.

The Empowered Patient Podcast is available online now and you can listen here and read the full the transcript here.

Celegence has proven experience with medical writing for regulatory eCTD submissions. Our deep regulatory expertise, combined with advanced AI-Enabled technology solutions, positions us uniquely to handle the complexities of medical writing. We ensure that every document is not only compliant but crafted to expedite approval processes and facilitate market access. For more information about our services can benefit your regulatory processes, contact us today.