Medical Device Testing

We make sure your medical devices are going to work properly before you put them out into the world. 

Services

We offer a range of services for medical device clients, including proof of concept testing, device characterisation, reliability testing, device verification, validation and lot release testing to ensure your device is safe and reliable.

Device Characterisation

- Understand how components and parts will behave.
- Make sure everything works together.
- Check whether something needs improvement or not.

Verification & Validation

We make sure your devices are going to work properly before you put them out into the world.

✔ Verify if the device and components work correctly.
✔ Validate if the device was built correctly.

Released Product

We offer independent testing services for all kinds of products.

- Lot release testing
- Complaint investigation

Device Verification & Validation Support

We simplify the design verification and validation process by providing complete design verification and validation support service within our certified ISO13485 quality management system and testing labs. 

01

Planning

Planning Identifies the best approach for conducting verification & Validation. Define what you will measure and how you will measure it.

We work with your senior engineers to create, and manage design verification and validation, allowing your team to focus on development

02

Developing

Where Product development really begins!
 
This part of the process also includes writing, test driving, and approving the test cases that will be used for verification.
 
We work with you to define test cases. Method design and development, Measurement system analysis while carrying out Test Method Validation.

03

Executing / Lab testing

Test procedures are executed in our verification and validation labs.
 
Any invalid results are documented and reviewed, and either accepted or logged as defects. From test execution, Defects are tracked and root cause analysis to trace matrix management.

We aid your team with experienced testers to ensure all testing is completed as planned.

04

Reporting

Reporting is performed at the end of each phase of verification & validation.
 
Detailed reports include release reports, test results by testing type or product version, and issues found during the verification/validation activity.

We work with QA, R&D and SME’s to create, compile and review all technical reports prior to design review.

Support

We work with you across all components of device testing in development. 

Requirement Reviews

Working with your development teams to refine and check the requirements for omissions on testable requirements.

Protocol Developmnt

Protocol and method development

Creating bespoke test methods against your established acceptance criteria suitable for intended use.

Test Method

Test Method Validation

Validation of your or our method to ensure the test is suitable for its intended purpose.

Data Analysis

Result Analysis

Reviewing and conducting statistical analysis on data generated as defined within test plans or test methods.

Test plan Generation

Using your requirements to Build verification and validation test suites for your product.

Packaging & Transport Validation

Validation of your primary, secondary and final packaging solution to international standards.

Measuremen Analyss

Measurement system analysis

Assessment of any and all measurement systems which may be used in development.

Failure Investigation

Anomaly Investigation

Conducting engineering investigations into any issues identified during testing.

Test Rig Generation

Creating, designing and validating test rigs for experimental use.

Cleaning & Sterilisation Validation

Working with you to develop and implement robust cleaning and sterilsation validation activites for your device.

Testing

Test Execution

Conducting and executing defined tests using our internal labs and technical team. 

Report Generation

Report Generation

Generating development reports for quality review and compliance.

iDE8_ Stability testing

Medical Device Testing

Get in touch for more detail or information on how we can support your test campaign.