Testing

We provide testing support for design and development

 

We provide testing to support the design and development of medical devices, including biocompatibility, feasibility, verification, and validation testing. We will utilize external testing laboratories when necessary.

Biocompatibility

We test devices for biocompatibility to evaluate compatibility with biological systems and ensure that devices interact safely with the human body and do not cause adverse reactions such as toxicity or inflammation.

Feasibility Testing

We test concepts for feasibility to assess the technical performance, manufacturability, and costs, and determine if the concept is practical and viable before proceeding to more advanced stages of development.

Verification Testing

We test verification prototypes to ensure that they meet their specified design requirements and perform as intended according to predefined criteria. We perform verification testing on prototypes representing the final product, with fully documented processes and material traceability using final protocols. We provide accelerated ageing and environmental conditioning testing if necessary.

Validation Testing

We test validation prototypes to ensure that they meet all of the user's needs. We support validation testing with devices produced using production processes and help qualified clinical personnel conduct testing according to released protocols.

What's the ROI on Better Product Development?

 

Better design and development drive measurable outcomes. Organizations that achieve improved product development enhance quality through better device usability and functionality, reduce the cost of product development and cost of goods sold, accelerate time to market for product launches and future product iterations, and increase innovation with more protectable intellectual property.


Our Approach

We simplify complex design and development challenges 

 

We help biomedical innovators understand complex challenges and create simply effective solutions. From concept generation and product brand strategy, industrial design and product development to verification and validation, we help commercialize biomedical innovations with our design and development services. 

Discovery

 

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.

APPROXIMATE TIMING: 1-2 DAYS

 

Assessment

 

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.

 

Approximate Timing: 1 week

 

Statement of Work

 

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.

 

Approximate Timing: 1-2 weeks

 

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Your innovation Just Might change the world. But is your design up to the task? We help you turn Just Might into Just Mighty.