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Simplifying SaMD regulatory compliance with AI-driven expertise

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Caroline Shleifer, founder and CEO of RegASK, outlines how AI is helping FMCG companies stay up to date on regulatory changes.

MUNGKHOOD STUDIO / Shutterstock.com

The intricacies of global medical device regulations, particularly those related to Software as a Medical Device (SaMD), are often overwhelming as manufacturers and stakeholders try to keep up. As demand for digital health solutions surges, the SaMD market is poised for significant growth, with a projected compound annual growth rate of approximately 52% from 2023 to 2028.

With an evolving regulatory landscape and the growing launch of SaMD solutions, ensuring the safety and efficacy of medical devices in global markets has become increasingly important. Whether you're an industry veteran or new to the field, understanding how software is regulated as a medical device is essential. Navigating the complex terrain requires a firm grasp of regional nuances, documentation requirements, and compliance processes.

Regulatory professionals play a pivotal role in facilitating the expansion of digital health companies into new markets while navigating diverse regulatory frameworks. Leveraging their expertise, experience, and strategic insights, they guide companies in enhancing compliance, reducing risk, and expediting market entry. In tandem, AI-driven regulatory tools streamline regulatory processes by promptly alerting professionals to global updates, as well as highlighting the implications of key changes.

Understanding global regulatory differences 

AI-driven regulatory platforms offer vital support, enabling proactive monitoring and swift adaptation to changing regulations. The platforms ensure professionals are promptly informed about upcoming regulatory updates and provide actionable guidance for addressing potential compliance issues. AI technology has also proven useful in other crucial areas such as quality management, documentation requirements, and clinical trial strategies.

While SaMD is subject to regulations similar to traditional medical devices in many countries, companies entering multiple global markets need to consider specific requirements. In the European Union, SaMD products require CE marking based on intended use and risk. In Australia, SaMD products must be registered in the Australian Register of Therapeutic Goods before marketing.

Across various Asian countries, regulatory frameworks vary, with Japan, South Korea, and Singapore having established systems. In the United States, the FDA classifies SaMD products as Class I, II, or III based on the level of risk involved. Understanding and addressing the distinct requirements is critical for SaMD companies and AI-driven regulatory platforms can play a crucial role in ensuring compliance and facilitating market access on a global scale.

Streamlining quality management, clinical trials, and documentation

AI-driven regulatory platforms assist regulatory professionals in guiding SaMD companies through pivotal phases of development and regulatory compliance. Whether it involves strategising for clinical trials in target countries, building and maintaining a Quality Management System (QMS), or reconstructing a Design History File (DHF) in compliance with global standards, the expertise provided by the systems simplifies compliance processes.

Clinical trials are essential for assessing the safety and efficacy of medical devices, including SaMD. Their results play a vital role in informing regulatory decisions and are often required as part of the pre-market approval process by certain regulatory bodies. AI-driven platforms enable clinical trial strategy development for target country pathways, supporting regulatory professionals in key areas:

A well-established QMS is the backbone of regulatory compliance in the healthcare and medical device sectors, offering a systematic and structured approach to ensure products meet regulatory standards while upholding quality and safety. For QMS, AI-driven platforms provide regulatory professionals with advanced tools and resources, providing support in various areas:

A company's DHF is a comprehensive record containing all design and development documentation related to its device. In several countries, including the U.S., DHF documentation is necessary for regulatory submissions. To achieve DHF compliance, regulatory professionals can leverage AI-driven tools to comply with global regulations. The technology assists in:

Supporting global compliance with AI-driven solutions 

AI-driven platforms are integral to facilitating global regulatory compliance for medtech companies. These platforms offer vital support to regulatory professionals, ensuring alignment with international standards in quality management. Compliance ensures product quality and safety while paving the way for expansion into new international markets.

The ever-changing nature of regulations, particularly in SaMD, emphasises the need for third-party regulatory professionals. AI-driven platforms support regulatory professionals in helping companies develop compliant QMS, navigate intricate regulatory pathways, and strategically position themselves for global market entry. With technology rapidly advancing, regulatory expertise isn't just a competitive edge — it's a vital asset for those advancing healthcare solutions on a global scale.

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