Validation And Verification

Looking for an experienced, trusted and independent regulatory compliant test resource?

Implementing The Quality Assurance Processes We Defined

Validation & Verification is a key part of the medical software development life cycle. As an end to provider, V&V is a critical part of the overall delivery. We have invested heavily in this aspect of our business, from people, to the latest in automation technologies. Some of the world’s leading blue-chip companies use BlueBridge Technologies as an independent regulatory compliant test resource. This is because we defined the quality assurance processes derived from ISO 29119, ISTQB and model-based testing best practices. Throughout the course of your software development life cycle, we design and implement various tests, with the quality and the completeness of the release fully evaluated. Then, the full suite of documented proof of device efficiency you require is delivered as design outcomes.

We provide this service as part of the overall drive for quality and compliance. This gives you, your clients and physicians the confidence that your products can be relied upon and trusted in the use of patient care.

What Our Validation & Verification Process Involves

The FDA defines verification as confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. It also defines validation as confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. At BlueBridge Technologies we can do both and ensure your system, software or device has been built correctly. We use manual and automated testing to ensure full test coverage and complete verification on both system and detailed design level. On complex systems, we deploy model-based testing to effectively manage testing complexity and assure full system coverage in shorter lead-times.

Why Companies Choose BlueBridge Technologies

We have a highly-skilled Validation & Verification team that regularly performs formal independent verification based on detailed documentation against design inputs. Our experts have extensive experience on design, build and validation of test tooling, as well as computer system validation. We can provide a complete system/user validation suite for you, including all IEC 82304/IEC 62304 and FDA guidance’s required documentation like plan(s), protocol(s), script(s), and report(s). What’s more, we can provide all necessary participant (sample) size calculations, as well as participant management (selection and compensation).

Our Independent Verification and Validation services improve software competence and comply with industry best practices. Cost effective, efficient and timely, they provide domain expertise you can rely on to ensure the highest-quality software product.

Core expertise

Cloud (SaMD)

Mobile (SaMD)

Device/Wearable

Supporting Disciplines

Validation And Verification (V&V)

Regulatory Compliance

Human Factors

Post market Surveillance

Connectivity

Data Science

Sensors & Electronics

Cybersecurity

Project Governance

Get In Touch

If you have the problem, we have the solution. To get started on your Validation & Verification journey, all you have to do is start by saying hello.

SAY HELLO