Empowered Patient Podcast Increasing Focus of Medical Device Companies on Regulations and Compliance with Sonia Veluchamy Celegence
Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access.
Sonia explains, "The awareness is there, but medical device companies have traditionally been a bit slower in adapting and bringing in consultancy, expertise, and technology. That is partly because the sector’s regulations have not evolved at the same pace as in the pharmaceutical industry. More recently, though, the regulations have become more complex. For instance, the requirements under the EU MDR- Medical Device Regulation – are very heavy in terms of the information that needs to be submitted on an ongoing basis. So, the industry is starting to recognize what it takes to maintain documentation, specifically detailing post-market surveillance activities, which is required to be compliant with the regulations worldwide."
"When you think about how medical devices are evolving, you get a sense of the growing complexity. For instance, there is now software that serves as a medical device. You also have AI being embedded into medical devices. But ultimately, it’s about ensuring that the products placed on the market are safe and efficacious. The ability to prove that via proper documentation is important. That, in turn, enables different regulatory authorities to feel comfortable with the products that are being approved and being marketed in each region."
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