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
This webinar will appeal to professionals involved in the development, testing, regulatory approval and commercialization of medical devices, including:
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
Register free on Xtalks: https://xtalks.com/webinars/accelerate-medical-device-market-access-with-home-use-compliance/
