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The International Medical Device Regulators Forum (IMDRF) released two key documents related to medical device software: Good machine learning practice for medical device development: Guiding principles (IMDRF/AIML WG/N88 FINAL:2025); and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents are aimed at improving g..

Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of sof..

Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that au..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Japan Regulatory Requirements - Medical Device Software▶ 일시: 2024년 08월 08일 CST 9시 (한국시간: 08월 08일 23시) As the global market for medical device software (SaMD) expands, navigating the regulatory landscape becomes increasingly critical for manufacturers. While many regions share similar regulatory approaches, Japan presents unique challenges and opportunities. Our u..

This is the third in our series of regulatory updates on the EU Artificial Intelligence Act (AIA). Since more than one month has passed since the law’s approval, we are providing this article ahead of the AIA’s publication in the Official Journal of European Union (OJEU). BackgroundOn May 21 2024, the EU AIA was approved and given the final green light by the EU Council. The AIA establishes requ..

The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Medical Device Software and Cybersecurity▶ 일시: 2024년 05월 14일 CST 10시 (한국시간: 05월 14일 23시)  As medical devices become more and more interconnected — and the applications of medical device software grow exponentially — there is a need to ensure that these devices, when placed on the market, are safe and effective and remain in this state throughout their lifetime. I..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..

유럽연합에서 소프트웨어와 결합할 수 있는 하드웨어 또는 하드웨어 구성요성에 따라 규제사항의 적용 및 조항에 대한 가이던스를 발표하였다 (MDCG 2023-4). [소프트웨어 (MDSW)와 결합 가능한 하드웨어 조건 리스트] 1. A회사에서 생체신호를 획득하는 HW 또는 HW components를 만들고, 이와 연동이 되는 SW도 제작하는 경우 2. A회사에서 생체신호를 획득하는 HW 또는 HW components를 만들고, B회사에서 HW 또는 HW components와 연동이 되는 SW를 제작하는 경우 3. A회사에서 스마트폰 또는 웨어러블 디바이스를 통한 생체신호를 측정하여 SW에 전달되는 경우 4. A회사에서 스마트폰 또는 웨어러블 디바이스에서 측정된 생체신호를, B회사의 SW (App)에 전달되는..