Service
With the increasing popularity of smart medical devices and digital healthcare, driven by artificial intelligence, the Internet of Things, and big data, the healthcare industry has entered a new era surrounding the rapid development of healthcare software and applications.
Telemedicine, mobile healthcare, and smart healthcare all rely on feature-rich software. Whether it is a health software/app that collects users' blood pressure, blood sugar and other data, or remote control of medical equipment for diagnosis and treatment, as well as the hospital's electronic medical record system/information management system, they are included in the scope of health software. Software as a Medical Device (SaMD) is a health software that is not intended to run on a dedicated hardware device.
Whether it is SaMD or health software, the development process and safety requirements need to be defined "in advance" by appropriate standards. For manufacturers, the entire life cycle of software needs to be considered, including product design, development, installation, verification, validation, maintenance, and processing, etc. The level of impact on patient or public health must be considered during the life cycle of the product and whether software as a medical device is treating/diagnosing or informing on clinical decision.
In fact, there are significant differences between SaMD and health software under the framework of regulatory requirements, including whether the actual software manufacturer is a medical device manufacturer in the strict sense or a general software manufacturer, as well as the intended use, intended environment, and usage scenarios.
Figure A.1 – Health software application domains and scope of related standards in IEC 82304-1:2016
We can provide evaluation and certification services for SaMD and health software to key industry standards:
These new services offer a certification option for SaMD and health software products, thereby demonstrating safety and efficacy of these products. Depending on the intended use, the connected hardware that hosts the SaMD may or may not be a part of the certification.
Obtaining independent third-party certification for your products can help you boost your brand reputation and increase consumer confidence, as it demonstrates your commitment to product safety and quality:
Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.
Our experts work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several testing laboratories globally.
We provide a single source for your needs, helping you save time and money. Our comprehensive suite of services includes end-product testing, certification, validation (EMC, wireless, safety, interoperability, cybersecurity, biocompatibility), and Global Market Access.
To learn more, contact us.
Our extensive laboratory resources and expertise in China can help medical device manufacturers demonstrate compliance to NMPA’s requirements and streamline access to the China market.
Evaluate compliance to IEC 60601, the standard for the basic safety and essential performance of medical electrical equipment.
UL Solutions offers testing, inspection, and certification services to customers navigate compliance for medical electrical equipment and systems in a home healthcare environment.
Explore the challenges of assessing software as a medical device (SaMD) and the importance of evaluating SaMD in accordance with a structured risk framework.
This on-demand webinar discusses the importance of the total product lifecycle in managing cybersecurity of medical devices, including post-market issues like their end-of-life, end-of-support, decommissioning, and disposal.
The market for home healthcare is growing as service delivery shifts from clinical to home settings. Manufacturers face challenges in supplying equipment that is both more effective and safer.
Successfully introducing on the market an advanced medical wearable device: Sidly case study.
Amendment 524B of the FD&C Act sets new U.S. FDA cybersecurity rules for medical devices. UL Solutions provides expert support to help manufacturers meet these requirements.
