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Determining Software as a Medical Device is essential for regulatory compliance. This involves classifying software as a Device Component, Accessory, or Standalone Device, and understanding FDA’s UDI requirements and the implications of software changes on device identification.
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’....
Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model and version of that device on the market.
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements...
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID?...
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for...
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation and regulatory submission requirements.
HORSHAM, Pa., May 18, 2021 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a...