V & V Testing

The smart way to extend your limited resources

While there are many testing labs that can generate data, we are an ISO 13485 certified and FDA compliant Medical Device Testing Lab that is led by product development professionals and is supported by in-house quality and regulatory team members.  Since we understand the entire device development process and what documentation belongs in a DHF as well as the submission filing, we know the critical difference between "generating data" versus "generating the right data".

More than just a Testing Lab.

So What Makes Us Different?

An Extension of Your Team

Whether you are a large or small company, we engage based on your company's unique realities, goals and priorities, not ours.

ISO 13485 Certified FDA Compliant Lab

Whether conducting an exploratory experiment or design validation, we understand the importance of operating our lab according to global requirements.

Holistic Testing Approach

Knowing how important the V&V data is to the success of your device development program, we challenge the study design and your plan if testing doesn't go as expected.

An Extension of Your Team

ISO 13485 Certified FDA Compliant Lab

Holistic Testing Approach

Whether you are a large or small company, we engage based on your company's unique realities, goals and priorities, not ours.
Whether conducting an exploratory experiment or design validation, we understand the importance of operating our lab according to global requirements.
Knowing how important the V&V data is to the success of your device development program, we challenge the study design and your plan if testing doesn't go as expected.

Features


Verification & Validation Testing

V&V testing is the critical evidence that demonstrates to regulatory agencies that the proposed medical device is designed right (verification) and that you've designed the right product (validation). We leverage our learnings from many medical device and combination product launches directly into your V&V testing plan and execution.

Full TMV Support

Before kicking off V&V testing, we can help you identify/design the test method & fixtures, and conduct the full test method validation (attribute or gage R&R).

Auxilliary Horse Power

When you need additional resources to conduct your testing and minimize impact to project timelines, leverage our experience, facilities and staff.

Issue Resolution & Options

Depending on the issue, we can help identify testing strategies and provide re-design recommendations.

Full TMV Support

Auxilliary Horse Power

Issue Resolution & Options

Before kicking off V&V testing, we can help you identify/design the test method & fixtures, and conduct the full test method validation (attribute or gage R&R).
When you need additional resources to conduct your testing and minimize impact to project timelines, leverage our experience, facilities and staff.
Depending on the issue, we can help identify testing strategies and provide re-design recommendations.

Full-breadth of Product Development Testing Needs

Due to our cross-functional product development expertise, we recognize and can support the various testing needs that may occur throughout a product development effort.

Understand Competition

We support early testing that may be critical to identifying and understanding the key performance characteristics of your competition and your device design requirements.

Support Your Submission

When developing your device, we conduct testing necessary to demonstrate performance as compared to your chosen predicate device and fulfill submission requirements.

Manufacturing Impact

We can conduct a Design of Experiments (DOE) to help you determine which design features are sensitive to proposed manufacturing process conditions.

Understand Competition

Support Your Submission

Manufacturing Impact

We support early testing that may be critical to identifying and understanding the key performance characteristics of your competition and your device design requirements.
When developing your device, we conduct testing necessary to demonstrate performance as compared to your chosen predicate device and fulfill submission requirements.
We can conduct a Design of Experiments (DOE) to help you determine which design features are sensitive to proposed manufacturing process conditions.

Some Unique & Specialized Product Testing Capabilities

Though we support product testing for a diverse set of Medical Technologies, there are a few specialties where our testing lab, cross-funtional services, and experience make us particularly helpful.

Needle-based Injector System Testing

ISO 11608-1 testing for pen-injector and auto-injector systems:  single-dose or mulit-dose.

Test Method Design and Validation

When an existing industry standard does not exist, leverage our expertise to develop and validate a test method, or validate your own existing test methods.

Software & Hardware V&V for Combination Products

In addition to managing the hardware V&V we can program manage the entire device system Verification and Validation process including software and embedded systems.

Needle-based Injector System Testing

Test Method Design and Validation

Software & Hardware V&V for Combination Products

ISO 11608-1 testing for pen-injector and auto-injector systems:  single-dose or mulit-dose.
When an existing industry standard does not exist, leverage our expertise to develop and validate a test method, or validate your own existing test methods.
In addition to managing the hardware V&V we can program manage the entire device system Verification and Validation process including software and embedded systems.

"Your team did a great job of delivering high quality work with an aggressive schedule for the (testing) project."

Sr. Manager, Engineering, Fortune 500 Medical Devices Company

V&V Testing +

Because EdgeOne Medical integrates your Product Development Services, you get more out of each component when they work together.

+ Quality

Discuss alignment of proposed testing with quality system requirements, and understand how test data influences your risk management file.

+ Regulatory

Develop testing strategies based on regulatory agency feedback from pre-market discussions or a submission deficiency letter.

+ Project Management

Collaboratively coordinate and prioritize testing activities to optimize timelines and include worst-case scenarios in the schedule.

+ Quality

+ Regulatory

+ Project Management

Discuss alignment of proposed testing with quality system requirements, and understand how test data influences your risk management file.
Develop testing strategies based on regulatory agency feedback from pre-market discussions or a submission deficiency letter.
Collaboratively coordinate and prioritize testing activities to optimize timelines and include worst-case scenarios in the schedule.

Questions?

Speak with a Product Development Specialist to learn more about our services.

Call 1-312-300-6640

Request a Consultation

Schedule a consultation with one of our experts about your specific needs.

Get Knowledge

Get answers and insights on the product development process from experts.

Access Blog

Questions?

Request a Consultation

Get Knowledge

Speak with a Product Development Specialist to learn more about our services.

Schedule a consultation with one of our experts about your specific needs.

Get answers and insights on the product development process from experts.

Call 1-312-300-6640
Access Blog