Systems Engineering

Case Study: Software architecture that supports business-model

 Problem: Client’s business model was selling disposable sensors to a manufacturing customer. Client needed an App to demonstrate capability, but didn’t have ability to produce top quality Apps. They wanted the customer's software team to very easily develop Applications that accessed their sensor data, both locally and over the cloud.  

Solution: Systems architecture that kept the sensor and bluetooth details hidden inside a software module, with a published interface. The Application Programming Interface (API) exposed a very easy to use way for App engineers to access sensor data. 

Result: Once API was released, a third-party customer wrote an App for Chinese users in less than 3 months.   

FDA Process Development

Case Study: Right-sizing development process to meet needs of a nimble Startup

Problem: Client’s business model required iterative development, some projects were large and complex and others simple. They needed a lightweight, yet compliant process that could be customized.

Solution: A Project-Oriented process. Each project started with a plan, which tailored the SOPs to its unique needs. Each project could make changes to any product and had its own DHF. Requirements were traced to archived test data when not changed and to new verification data as needed.

Result: Client could easily scale projects with a minimum of overhead, yet still pass comprehensive audits.   

Outsourcing Project Management

Case Study: External Development of Software for FDA Regulated Market.

Problem: Client needed to develop complex medical device software but did not have staffing or skill set to do it in-house.

Solution: Bishop selected out-sourcing contractors, wrote detailed specifications and acceptance test plans. Bishop managed vendor contact, resolved issues and communicated regular status to upper management.

Result: Software was developed on time and met all functional requirements and customer needs.