The medical industry has long embraced mobile technology to streamline clinical workflow and improve patient care. Nonetheless medtech is highly regulated to protect patient safety. With the help of UL’s experts, manufacturers can fulfill regulatory requirements and save time in rework and retesting to get their wireless medical health or mHealth devices to market on time.
Drawing on more than 100 years of expertise in product safety science, today UL tests and certifies wireless medical devices to EMC, radio performance, Wi-Fi, and other standards. UL, in conjunction with the Association for the Advancement of Medical Instrumentation (AAMI), developed interoperability standards AAMI-UL 2800 for mHealth technologies and other medical devices to address critical safety risks in complicated clinical environments and patient data.
We are perfectly positioned to guide manufacturers through the complicated compliance process. UL makes that process as smooth as possible, so that tested quality wireless medical products are launched on time and successfully into the healthcare and medical sector.
With the help of UL’s experts, manufacturers can fulfill regulatory requirements and save time in rework and retesting to get their wireless medical health or mHealth devices to market on time.
Why is mHealth Testing Important?
Most countries require medical devices to comply with mandatory product safety regulations. For example, manufacturers and importers of mHealth technologies in the European Union (EU) need to comply with EU requirements to sell their products in EU member states.
Early engagement with UL means that manufacturers of mHealth technologies can identify and address gaps in standards conformity at the design stage and avoid costly delays due to noncompliance.
Well-recognized by many international regulatory organizations, UL’s testing, certification, and laboratory facilities around the world provide leading services and support successful product launches in the major global markets. UL is constantly advancing the future of safety. Our innovations, combined with our independence, make us a benchmark of trust worldwide. UL is ready to guide you right from the very first design phase up until your product is ready to launch, listening each step of the way: to you, to the industry, to consumers.
Global Market Access
UL helps to simplify multiple market compliance by bundling product tests and certifications to meet all relevant national and regional market standards. Regardless of your location, this ‘one-stop-shop’ simplifies the process, reduces administrative and project management costs, and accelerates access to global markets.