RMF Medical Instruments Risk Management System











This client is the initiator of GessNet™ from US, he has extensive experience in the field of quality management and risk control.  He is mainly engaged in medical device quality control related consulting and training.

Our client plans to develop an automated and highly integrated risk management analysis software (RMF). The target customers of this software are medical equipment suppliers, manufacturers, consultants and related risk authoritative institution (FDA). There are a number of partners, who have extensive experience in the field, but the cost of developing is paid by the client himself. 

In the beginning of the project, the customer’s development team in US completed the database and architecture design. After understanding the advantages of our company's service quality and price, he gives us the outsourcing project to us.


Since 2011, Nova has been assisting the client in developing their software system. After the completion of the initial version, the client had a vision to package and sell it to medical enterprises. Through years of conceptualization by the client and continuous collaboration with Nova, the software system has continuously improved. However, due to outdated technology, Nova started assisting the client in a comprehensive system overhaul in 2021, resulting in significant improvements in performance and user experience. Thanks to the high-quality service provided, Nova gained the recognition of the client. As a result, the client has maintained a long-term partnership with Nova for over 10 years, and they still maintain a team of five people at present.
imageTechnical Key Points
  • Deploy environment: Window Server 2003, SQL Server 2008 R2, IIS7
  • Develop environment: Virtual Studio 2010, Telerik,  C#, JavaScript/JQuery/GoJs
imageKey event
  • 2011-04 Project kick-off, Nova prepare for development team, finish project requirement organize and handover
  • 2012-01 Complete project Beta 1.0 version
  • 2012-03 Publish official version 1.1
  • 2012-05 Expansion of new features, optimization of FMEA table and FTA Chart
  • 2012-10 Change interface, enhance the user experience
  • 2012-12 Publish official version 1.5, project version stable
  • 2013-06 Project maintenance, function enhancement, optimize performance, repeatedly publish version
  • 2013-08 Publish official version 3.1
  • 2013-2021 Doing some new functions
  • 2021- now A new version with new tech was published




  1. Client is busy, limited time for communication.
  2. Highly specialized business knowledge.



  1. Client will invest 2-3 hours a day on the project, we will prepare for requirements understanding in advance, and then have voice communication with customers. After that we will send the communication result to client for confirmation. This is very high efficiency.
  2. Organize business knowledge, search on web and purchase books on business expertise. In the communication process we use prototyping tools, flowcharts to identify requirement with the client to ensure a consistent understanding of the requirements on both sides.
imageDocuments management

1、No detailed requirement document
2、Unable to track requirement, design and test document

1、Requirements are raised mostly by oral expression, we will collate and summary form requirements into document.
2、In the middle of software development, we use the software's own function for document management. We use it to track design and test documentation; through this action we can also test the software function.

imageDevelop and maintenance

1、DB design does not match business requirement completely
2、High coupling  of project framework , not conducive to expansion
3、Key function is complicated, hard to maintenance

1、After communication with client, database design was partial adjustment, so that it can be more adapt to business needs.
2、Restructure the frame and code to make the project robust and easy to expand.
3、encapsulates core functionality into business components, reduce duplication of code, improve project quality, and make maintenance easier 

imageQuality Control

1、Client has special requirement on UI and design
2、Client wants trial users and partners to see more new features, but these features may also need to be continually optimized, we cannot deliver them to the product website 
3、It’s easy to loss document and remain not updated data when publish the final version.

1、organize UI and design requirements, according to the company's code standards, we set up the project specifications
2、In addition to deploying the product website, a test site and a trial site are deployed in order to meet customer demand. 
3、Publish the release process, follow the process during each release to ensure the correctness of release. Meanwhile release must be fully tested on the test site and the trial site until the product is deployed to the formal site. 


imageAchieve success

Client signed contract consulting and software service with multiple companies, and a number of potential users are using the product

imageenhance the professional field influence

Through the practice of software, client verified some risk management methods and quality control techniques, improved his influence in the professional field 

imageImprove quality

Improve end-user companies’ competitive advantages in productivity, product safety, quality and regulatory compliance

imageSave cost

By reducing investment in risk management, save a lot time of management

imagePartnership with the FDA

Because the software has complete function on risk analysis and quality control , it can automatically generate reports which will be audited by FDA. Client has established a good relationship of cooperation with FDA, such as the FDA jointly publish technical articles with FDA, customize some requirement for FDA, etc. 



customize risk management parameters, such as status, priority, risk policy (severity, probability and acceptability matrix) and so on.


risk analysis, fault tree analysis FTA, Failure Modes and Effects Analysis FMEA 


Risk Lifecycle Management and Version Control

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