TPLUS, a Korean healthcare solution provider, said it has obtained Europe’s CE Medical Device Directive certification for “View Vine,” a picture archiving and communications system (PACS).
With the certification, the company can attach the CE mark on View Vine products sold overseas.
|View Vine, a picture archiving and communications system (PACS), by TPLUS|
European authorities issue the CE MDD only to medical products that pass strict standards for safety and efficacy. For a Korean medical device to enter the European market, its manufacturer must receive the certification for the product.
TPLUS drastically removed functions that are less frequently used for reading and managing medical images and focused on the core functions of the PACS. “It is suitable for domestic small- and medium-sized hospitals and hospitals in under-developed countries to manage medical images,” an official at TPLUS said.
With the CE mark available on View Vine in the global market, TPLUS plans to seek more aggressive approach in exporting the product to the Middle East, Africa, Southeast Asia, and Europe, TPLUS said.
The company is also developing a solution using a blockchain to store and transmit medical images of PACS safely.
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