Regulatory Affairs Department: The Immune System that Defends and Enhances Product Competitiveness

At aetherAI, alongside the product development team, our Regulatory Affairs (RA) partners form a nimble task force. As our products—such as the digital pathology system and AI-assisted diagnostic applications—are built from scratch or updated, this team ensures that they strictly adhere to regulatory standards. At the same time, they adapt strategies to maximize product value within the regulatory framework.

More Than Gatekeepers – Strategic Experts in Agile Response

udy, a medical device regulatory specialist at aetherAI, plays a core role in this battleground. Her responsibilities span design development, documentation of design changes, and handling product registration and inspections.

Day to day, she supports the product development team by producing required regulatory documents and managing licensing—such as the renewal application for the digital pathology platform (aetherSlide) and the export license for the bone marrow smear analysis software (aetherAI Hema-BM18). Her work ensures that each product obtains official approval before launch and remains compliant after entering the market.

Due to the strict requirements of medical regulations, RA must closely collaborate with multiple departments. "Our work involves extensive cross-departmental communication, especially with the product development team. They are responsible for developing products and writing technical documents, while we ensure that product documentation meets regulatory requirements, allowing products to pass review smoothly."

This collaborative model influences not only product timelines, but also the company's overall compliance and competitiveness. In addition to ensuring product compliance, Judy acts as a strategic player, laying the groundwork from the product design and development stage. She ensures regulatory compliance throughout the process, helping products enter the market smoothly while maintaining their competitive edge.

Judy's work is not just defensive; it is proactive, making regulations a part of strategic advantages, rather than a constraint.

Regulations as Both Threshold and Moat

The medical device industry encompasses a wide range of products, each subject to different regulatory standards. Judy possesses professional understanding and experience regarding these regulations, enabling her to provide appropriate support in her work.

"Currently, the main regulations for medical devices include Taiwan's Medical Devices Act, the U.S. FD&C Act, MDR, Regulation (EU) 2017/745 and IVDR, Regulation (EU) 2017/746. Depending on the product characteristics, additional standards or guidelines may apply. For example, software must also comply with IEC 62304, which defines the lifecycle processes for medical device software,” Judy explains.

Learning and applying these evolving standards is a constant challenge in RA work—especially in the fast-changing field of AI-powered medical devices. These regulations can be seen as obstacles to market entry, but Judy sees them differently. “They're a form of technical barrier. If we overcome them early, it becomes harder for competitors to catch up,” she says. Judy stays current with regulatory trends across countries and actively engages with authorities to smooth the approval process.

RA isn't just about getting products to market; it's also about ensuring ongoing compliance, safety, and performance. Through the efforts of the regulatory team, medical regulations are no longer just restrictions but a part of aetherAI's technological strength, pushing aetherAI's products to a higher competitive level.

A Key Defense Line for Stable Quality

Beyond product registration and compliance, Judy also supports the company’s Quality Management System (QMS), especially in maintaining documentation aligned with ISO 13485. These documents affect daily operations and are crucial for passing annual external audits.

“Each year we prepare for the ISO 13485 audit to confirm our quality system is running as expected,” she says. During audit season, the RA team works closely with QA (Quality Assurance) team to compile extensive documentation, knowing exactly where each file is stored for quick retrieval during reviews.

“Audits aren't just RA or QA’s responsibility,” Judy notes. “They involve every phase of company operations—procurement, project acceptance, and more—all of which must meet regulatory standards.”

Hence, attention to detail and strong communication skills are essential in this role. Judy must not only identify compliance gaps in documents but also coordinate solutions with relevant teams across the company.

Venturing into Medical Device Software

Judy's career began in traditional medical device product development, gradually transitioning into the regulatory field. Upon graduating from a chemistry-related program, Judy did not choose to enter the semiconductor industry like most of her peers but instead ventured into medical device product development. During the development process, she gradually realized the importance of regulations for medical devices and decided to focus on RA work. Her regulatory experience spans consumable medical devices and in vitro diagnostic reagents, and she now focuses on regulatory management for medical device software.

Technology and regulations are constantly evolving. This makes continuous learning a professional requirement in the medical device regulatory field. Judy not only seeks advice from senior colleagues within the company, but also keeps a close eye on regulatory trends. She actively participates in courses related to medical device regulations to stay up to date.

She explains, "By keeping a close eye on regulatory trends and taking professional courses, we can grasp regulatory requirements and changes more swiftly, which greatly aids our work."

Although initially hesitant about transitioning to the medical device software field, Judy soon discovered at aetherAI that it offered an entirely new learning opportunity. "I later found that the characteristics of AI medical device software often apply to IVD (in vitro diagnostic medical devices), and this overlap in regulations gave me greater confidence to take on new challenges," Judy adds. Despite the long and complex journey from concept to market, seeing a product evolve brings her a deep sense of accomplishment.

Roles like Judy's in RA are not just gatekeepers of product compliance but also vital bridges for product development and market advancement. Faced with shifting regulatory landscapes, her learning and adaptability enable her to continue developing across different fields and provide robust regulatory support for the company's products. "I hope that through the ongoing dedication of RA, aetherAI's high-quality medical device products will be adopted worldwide, ultimately benefiting more healthcare professionals," Judy concludes.

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