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.

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:

  • Regulatory landscape analysis: The systems can provide real-time updates on regulatory requirements and guidelines for clinical trials in specific countries, ensuring strategies are up to date.
  • Patient population selection: AI tools can analyse demographic and medical data to aid in the selection of suitable patient populations.
  • Data collection and reporting: AI-driven systems can streamline clinical trial data collection, management, and reporting, ensuring adherence to regulatory authorities' specific requirements.
  • Risk assessment: The platforms can assist in identifying potential risks and challenges related to clinical trial strategies, enabling proactive mitigation.

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:

  • Customisation: The systems can assess the specific requirements of the SaMD product and customise the QMS to align with its unique needs.
  • Automation: The platforms can automate various quality control processes, including document management, change control, and risk assessment.
  • Compliance monitoring: AI tools can continuously monitor regulatory changes and ensure the QMS is promptly updated to maintain compliance.
  • Data analysis: AI technology can efficiently process large volumes of data, pinpointing areas for improvement within the QMS.

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:

  • Template and guideline adherence: AI tools can provide templates and guidelines that align with global standards, ensuring that the structure complies with regulatory requirements.
  • Documentation analysis: The systems can analyse and catalogue every facet of the SaMD's design and development process, streamlining the tracking and reporting of the product's history.

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.