Software Quality Assurance

Healthcare Startup Company needs to create a Quality System

Situation:

Early Stage Healthcare Technology Company working on the next generation of healthcare products needs the proper Quality Assurance Documents put in place for developing Medical Device software.

Task:

To develop the Software Design Controls portion of their Standard Operating Procedures (SOPs) and to provide feedback on their Design History File artifacts.

Action:

IQ team evaluated the company’s current Agile software development process and their existing set of documentation. IQ provided some general training to the team to understand the difference between SOPs and product specific deliverables, and the type of content that goes in SOPs, Work Instructions and Forms. The IQ Team then created the SOPs to support this process, as well as their Agile development process.

Result:

IQ team delivered a simple but effective set of SOPs that were compliant with the IEC SW62304 standard for developing Medical Device software.

Mobile Eyecare Company needs to update their Quality System

Situation:

Late Stage Startup Company has developed a product using Agile Software Development Methodologies. The current software development process had some inconsistencies with the documented Standard Operating Procedures.

Task:

To make the SOPS compliant with the Agile development process, validate the Agile Development tools, and provide an assessment of the current Design History File (DHF).

Action:

The IQ team evaluated the SOPs, the DHF, JIRA tool and the current Agile Process. The IQ Team worked together with the customer’s SCRUM Master to put a process in place that incorporated what was needed to be compliant with the Quality System, while still maintaining an Agile Development process.

Result:

IQ team made the necessary adjustment to the SOPs, recommended and trained on a revised Agile Development Process, provided a template for Tool Validation, and worked together to improve upon the artifacts within the DHF.