Service Levels

We offer a large selection of testing tailored to meet individual device requirements. Our four service levels are designed to provide the exact engineering support needed at the different stages of the device development process.

 


FAST TRACK

Our FAST TRACK level is designed to help engineers in their everyday work to make rapid design decisions.

FAST TRACK SERVICE can be used to optimize R&D work ahead of any design lock activity or prototype validation. Tests offered through our FAST TRACK will be based on applicable test standards and guidelines without any traceability or proof of compliance. Tests eligible under the FAST TRACK level can be completed within 1-2 weeks (depending on our work load and the number of samples to be processed).

NOTE: At least a STANDARD SERVICE must be used for first time tests, subsequent testing used for design iterations may be performed under FAST TRACK. Not all services are available at the FAST TRACK level.

Deliverables
Basic test sheet and raw data only.

STANDARD SERVICE

Our STANDARD SERVICE level is designed to support R&D engineers needs outside regulatory submissions requirements.

Standard service can be used to conduct feasibility studies and provide input to properly structure any Verification and Validation (V&V) studies and provide preliminary input on device performance.
Preliminary performance input can be used to define proper sample sizes required for non-attribute tests.

Deliverables
Basic protocol based on applicable standards without rationales. Basic report with deviations, data post processing, test method description, and apparatus.

FULL SERVICE

Our FULL SERVICE level is offered to cover device Verification and Validation (V&V) test requirements in relation to regulatory submissions.

Our most common service offer is designed to address device performance in depth. Our engineers can provide assistance in combining tests to optimize execution time and minimize test samples burn rate. In order to increase chances of success, we recommend conducting initial feasibility studies to the streamline and de-risk V&V testing.  Study plan with anticipated delivery date will be provided upon starting the complex large studies involving several tests (more than 4 tests), or test stretching over a long period of time.

Deliverables
Comprehensive protocols with justification and rationales,  data interpretation/analysis acceptance criteria, and test method description. Comprehensive final report in compliance with applicable standards listing all deviations, data post processing, relevant statistical analysis, test method description, and apparatus. Engineering and Regulatory support for submissions.

FULL SERVICE WITH ISO 17025

Our FULL SERVICE with ISO 17025 level is offered to cover device Verification and Validation (V&V) requirements in compliance with ISO 17025:2017.

In addition to the offerings of FULL SERICE, ISO 17025 offers additional documentation and quality assurance oversight to ensure ISO 17025 requirements.

Deliverables
Comprehensive protocols with justification and rationales, data interpretation/analysis against acceptance criteria, and test method description.  Comprehensive final report with deviations, data post processing, relevant statistical analysis, measurement uncertainty, test method description, and apparatus. Plans and reports are in compliance with applicable standards, and include a certificate of compliance with ISO 17025:2017.   Note: Only accredited tests which fall within the scope of the current certificate (here or here) can be endorsed as accredited.

ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

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