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.
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.
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
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.
Client signed contract consulting and software service with multiple companies, and a number of potential users are using the product
Through the practice of software, client verified some risk management methods and quality control techniques, improved his influence in the professional field
Improve end-user companies’ competitive advantages in productivity, product safety, quality and regulatory compliance
By reducing investment in risk management, save a lot time of management
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