Accelerate Medical Device Market Access With Home-Use Compliance
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About this webinar
The shift towards home healthcare is transforming the medical device industry. Driven by ageing populations, the growth of remote patient monitoring and increasing demand for patient-centred care, more medical devices are now being used outside traditional clinical settings. While this presents significant opportunities for manufacturers, it also introduces new safety, usability and regulatory challenges that must be addressed before products can successfully reach the market. This webinar explores the testing and compliance requirements for home-use medical devices and how manufacturers can navigate regulatory pathways to support medical device market access.
The session will examine critical testing and compliance considerations for medical devices intended for home healthcare environments. Attendees will gain an understanding of IEC 60601-1-11, the international standard that supplements IEC 60601-1 and defines the additional requirements for medical electrical equipment used in home settings. The featured speaker will examine how factors such as user interaction, electrical safety, electromagnetic compatibility (EMC), environmental durability and software reliability can impact device performance and regulatory acceptance.
The webinar will also provide an overview of the US FDA regulatory landscape, including medical device classification pathways and the role of robust conformity assessment data in supporting regulatory submissions. Particular focus will be given to the Nationally Recognized Testing Laboratory (NRTL) certification and the FDA Accreditation Scheme for Conformity Assessment (ASCA) program. The discussion will examine how ASCA-accredited testing laboratories can help manufacturers strengthen submissions, reduce review uncertainty and streamline the path to market.
By understanding the unique demands of home healthcare testing and engaging with accredited testing partners early in the development process, manufacturers can reduce regulatory risk, avoid costly delays and improve confidence in device safety and performance.
Register for this webinar to learn how home-use compliance requirements, NRTL certification and FDA ASCA-accredited testing can support medical device market access.
Who should attend
- Regulatory Affairs Managers and Specialists
- Quality Assurance professionals
- Medical Device Design and Development Engineers
- Product Development and R&D teams
- Compliance and Certification Managers
- Electrical Safety and EMC Engineers
- Software and Cybersecurity Engineers for medical devices
- Clinical and Human Factors Specialists
- Medical Device Manufacturers developing home-use or connected healthcare products
- Companies preparing FDA submissions, including 510(k) applications
- Professionals responsible for market access and product commercialization strategies
What you will learn
- The unique safety, usability and performance requirements for medical devices used in home healthcare environments
- How IEC 60601-1-11 complements IEC 60601-1 and influences product design, testing and risk management strategies
- Key testing considerations, including EMC, electrical safety, human factors, software validation and cybersecurity
- NRTL certification and its benefits
- How FDA ASCA-accredited testing can help reduce regulatory uncertainty and support more efficient medical device market access
Featured Speaker
Lydia Blake Webster
Information coming soon.
Partner for this event
Element Connected Technologies & Mobility
Element Connected Technologies & Mobility, a specialized business unit of Element Materials Technology, is a leading provider of testing, inspection, and certification services for connected devices and mobility solutions. Operating from 17 specialized laboratories across the United States, United Kingdom, Germany, China, South Korea, and Japan, our team of 1,200+ technology experts help manufacturers accelerate time-to-market for consumer electronics, IoT devices, autonomous vehicles, and medical equipment. We provide comprehensive testing and certification services that ensure products meet international standards for connectivity, interoperability, and safety. As part of Element’s global platform, we combine deep connected technology expertise with the broader capabilities of one of the world’s leading testing partners.