Medical devices lead to a direct impact on the patients’ lives. In order to deliver a safe experience for the patients, the industry has been coming up with continuous innovation in its software. However, there still are huge chances of the software filled with bugs and defects.

Optimum offers an innovative design for the successful verification and validation of medical devices. This testing undergoes an end-to-end life cycle involving a lot of tools, people and processes. Our testing design, execution and documentation are completely based on to producing a quality program that allows us to achieve client’s business benefits.

How we work?

We follow a five-step process that includes the analysis stage, design phase, deployment phase, closure phase and maintenance phase.

1. Analysis phase – Optimum’s team determines the scope of the equipment and regulatory compliance needs. The analysis is followed by a plan, approach and a test methodology. The plan further undergoes a validation as a whole, along with a review of the documents required. This also goes to the analysis stage of risk and impact assessment, design qualification, metric and communication framework and ultimately the validation of master plan.
2. The design phase includes finalising the validation plan, protocol development, building a validation approach, SEO development, validation training, collaboration with the client for testing needs and final sign off from the client.
3. Deployment phase – We then move to the smoke testing environment, get code reviews, test execution, verification and authentication of the documentation suite, defect sorting and retesting and the final execution summary.
4. Closure phase– post the deployments, we produce the hardware and software test execution summary report. Other reports include defect summary report, metrics and SLAs, system release dashboard, best practices, and the learning lessons.
5. Maintenance phase – Finally we take care of the maintenance of the device. This includes change control strategy, risk and effect valuation, change request, approval of the request, revalidation and ultimate system release.

Why Us?

Our certified team of professionals, a complex framework and the 5-step robust process is the primary reason why we promise premium services.