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RainMed Medical is Applying for MDSAP to Accelerate Its Layout of International Marketing System

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  • Time of issue:2023-02-24 10:50
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(Summary description)Recently, RainMed Medical is applying for MDSAP (Medical Device Single Audit Program). It is expected that the MDSAP certification issued by international authoritative certification body will further lay the foundation for RainMed's global development strategy.

RainMed Medical is Applying for MDSAP to Accelerate Its Layout of International Marketing System

(Summary description)Recently, RainMed Medical is applying for MDSAP (Medical Device Single Audit Program). It is expected that the MDSAP certification issued by international authoritative certification body will further lay the foundation for RainMed's global development strategy.

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2023-02-24 10:50
  • Views:
Information

Recently, RainMed Medical is applying for MDSAP (Medical Device Single Audit Program). It is expected that the MDSAP certification issued by international authoritative certification body will further lay the foundation for RainMed's global development strategy.

 

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia (TGA), Brazil (ANVISA), Canada (HC), Japan (MHLW) and the United States (FDA). The audit will be conducted by an auditing organization authorized by the regulatory authorities of the five countries.

 

 

As a Chinese independent innovative enterprise, RainMed Medical expands its global business on the basis of clinical practice, aiming to create world's leading high-quality innovative medical products. RainMed Medical’s caFFR system is the first innovative medical device product in China to obtain both CE marking and NMPA which puts forward the concept of coronary functional diagnosis and treatment based on angiograms without pressure guide wire, hyperemic agents and additional surgical operation. Based on only two angiograms, real-time aortic pressure, and an optimized CFD algorithm, caFFR could be measured in an average of 5 minutes, with an accuracy of 95.7%. Compared with traditional guide wire-based FFR, it has unique advantages of high efficiency, precision, simplicity and innovation, contributing Chinese wisdom to promote the clinical application of coronary function assessment.

 

Currently, RainMed has three authoritative medical device registration certificates and successfully completed its registration in the Republic of Serbia and the Republic of South Africa. Its advanced diagnosis and treatment concept and caFFRs excellent clinical value have been widely recognized by official institutions, experts and scholars, and passed the test of the capital market. Obtaining the MDSAP certificate means that RainMed will further improve the efficiency of its quality system audit, optimize the time and resources, and reduce the production interference caused by it. The acquisition of MDSAP certificate will also make RainMed Medical take another solid step to accelerate its layout of international marketing system, unlock new overseas markets, promote products and benefit the majority of patients.

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