QA & RA 

Research & Design

The majority of R&D activities are conducted in-house at 3R. 
Our specific R&D capabilities include:

•  Computer-aided Design (CAD)
•  Mold Design
•  Polymeric Dipping & Curing Process     

•  Mock Circulation Loop Design
•  Flow Visualization & Particle Imaging
•  Finite Element Analysis
•  Computational Flow Dynamics Analysis 

•  Artificial Neural Network & AI-based Flow
   Estimator Design
•  Condition Monitoring & Trend Analysis 

•  Printed Circuit Board (PCB) Design
•  Feedback Control Logic Design  


3R has established both in vitro and in vivo system testing capabilities.

In vitro performance and reliability tests are conducted in-house using the self-developed mock circulation loop and system reliability test rigs as shown below.

In vivo safety studies are performed in collaboration with the National Cheng Kung University and the National Laboratory Animal Center, National Applied Research Laboratories. Acute and survival animal studies have been carried out to verify the hemodynamics performance of the device, safety of the implantation method and biocompatibility of the implantable components.

Mock Circulation Loop

3R has developed a Mock Circulation Loop (MCL) with high-fidelity simulation capability to test the hemodynamic performance of a device. The MCL serves as the foundation in assisting our trigger detection algorithm design and VIGOR System performance evaluation.

System Reliability Test Rigs

3R has constructed multiple mock loop test rigs to support the testing of VIGOR System reliability in long-term use. These System Reliability Test Rigs can be oriented in different angles to simulate the gravitational effect of patient postures on blood sac reliability.


3R manufactures >90% of VIGOR System components in-house. 3R is equipped with a 330 m, ISO 7 (Class 10,000) clean room and a machine shop.

Our specific manufacturing capabilities include:

  •  Computerized Numerical Control (CNC)   
     Mechanical Manufacturing
  •  Dip Molding
  •  Injection Molding
  •  Laser Cutting & Polishing
  •  Polymer Solution Processing 

 *Automated Dip Molding Timelapse Video


R&D, testing, and manufacturing activities at 3R are strictly monitored and regulated according to ISO 13485 and FDA 21 CFR PART 820 requirements.

We aim to achieve ISO 13485 certification by Q4 2023 with one of our products, which will serve as an attestation to the quality and integrity of our company’s management and operation.


No. 90, Luke 5th Road, Luzhu District, Kaohsiung City 821, Taiwan