FAQ
General
Where are you located?
We are geographically located approx. 60 miles (96 km) north of Seattle Washington and 60 miles (96 km) south of Vancouver British Columbia. This southernmost tip of Canada is easily accessible by commercial air travel, car, or ferry. We encourage you to visit, so please contact us.
How long has ViVitro been in business?
ViVitro is an established company that has been in existence since 1984. We provide laboratory services and products to large and small companies from all over the world. As a Starfish Holding company, we leverage in addition to our own staff, a large scale in-house manufacturing facility, product development engineers, quality assurance personnel and support staff.
Laboratory Services
What types of Laboratory services do you provide?
We specialize in hydrodynamic, durability, and flow visualization testing of cardiovascular devices. These include tests indentified in ISO 5840 and the FDA guidance document;
- Hydrodynamic verification ISO 5840
- Durability assessment ISO 5840
- Flow Visualization assessment ISO 5840
- Other cardiovascular testing, including hydrodynamic and flow visualization
- Other design specific testing
What type of flow visualization can you perform?
ViVitro Labs offers the most advanced flow diagnostics capability with our in-house time resolved digital particle image velocimtry (DPIV) system. With a proper understanding of pulsatile flows, fluid dynamics triggers for disease such as shear stresses and turbulent shear stresses can be quantified with a high degree of accuracy. We are well staffed and have the capability to provide time-resolved, phase-averaged and time-averaged fluid dynamic analysis. Advanced methods such as proper-orthogonal decomposition also allow for capturing the implicit fluid mechanical phenomenon of interest. Our system has been used to study prosthetic heart valve, LVAD, TAH, blood pumps and other cardiac devices by qualitative and quantitative assessment of fluid motion using DPIV of hemolytic and thrombogenic potential using higher shear stresses as indicators of thrombogenic and hemolytic potential and high turbulent stresses as an indicator of thrombogenic potential.
After contacting you, when can you start testing?
Once we have received confirmation of your testing intentions, we can provide a test protocol, which once approved we can begin testing in days. Instances requiring fixtures or mounts will require additional time to produce, however our in-house manufacturing capability allows for fast turnaround. ViVitro Labs has ample amounts of equipment and with the advantage of using our own products you can expect outstanding expertise. We can easily add capability with our own stock alleviating availability issues.
How long will the testing take?
The typical hydrodynamic or flow visualization test can be completed in 30-45 days. Provided below is a guide for durability testing at difference cycle rates:
AWT
To 200,000,000 cycles at 800cpm (~ 180 days) at 1000cpm (~ 140 days)
Quasi Real-time Durability
To 80,000,000 at 200bpm (~ 278 days)
May I visit your facility to observe the testing?
Yes. We are always pleased to have clients observe or work side by side. Your involvement in testing can be as simple as email or video conference to in-house observation and assistance.
Will you offer protocols for testing?
Yes. In most cases, we have standard protocols that can be used “as is” or modified to meet your needs. Per ISO/IEC 17025 compliance we have standard test protocols for ISO and FDA testing as outlined above. We can create regulatory quality test protocols and reports to ease your burden of submission or simply provide a report brief for proof of concept or feasibility testing. Our experience in conducting regulatory studies for a variety of products provides you with the confidence that your results will withstand the highest degrees of scrutiny.
What are the sample size requirements for standard tests?
Sample size requirements are generally stated in regulatory standards. A guideline to consider is three test article and one reference (control) for hydrodynamic and durability assessment per size. Durability testing however is extended to 5 test article and one reference to fill a tester and is recommended to increase confidence. Other considerations and recommended for percutaneous valves are geometry, compliance, and deployment. We work closely with regulatory bodies to stay abreast of the latest concern so we can recommend the best matrix of test conditions.
Are Reference (Control) valve(s) provided for testing?
No. While we may be able to assist in the choice, the procurement is the responsibility of the client. You should consider that the guideline for reference valve choice is outlined in the standards documents and should be followed to ensure acceptability of the results.
What is required of valves that are shipped for testing?
Please ensure device containers are approved for transport. The device should be shipped in appropriate solution and the container must not leak. For regulatory testing a temperature indicator should be used. Please mark the devices appropriately.
Can you conduct testing for feasibility, proof of concept, or for design or product development purposes?
Yes. We will construct a test protocol to meet any of your needs. We enjoy the challenge of testing cardiovascular devices and find that a team partnership is the best way to advance your product development. We will conduct testing as simple as a daily rate for simplified studies up to full submissions acting as a R&D overflow facility.
Products
Where are your products available?
We are adept at providing equipment to any country. Our clients are located throughout the world. We have shipped goods to 39 countries over 5 continents. We are very familiar with custom requirements and can assure your product is delivered without incident.
Do your products meet CE Marking?
Yes. ViVitro products are manufactured in an ISO 13485 certified facility and comply CE marking in accordance with Applications Council Directives 2006/95/EC and 2004/108/EEC for standards EN 61010-1 and EN 61326-1.
Can your products operate at 230 VAC/50 Hz?
Yes. ViVitro products are configured to meet all power requirements. Each order is accepted for the specific power requirements of the country of destination. Product is converted and tested at 120 or 240 volts. Please specify voltage requirements (120/240 VAC, 50/60 Hz) and plug type (NA, EU, UK) when ordering.
Do your provide installation and training?
Yes. We provide installation and training to any location. To ensure your product is properly installed and meets your expectation, it is recommended that we install the system and conduct a complete training session. This not only provides you with assurance for proper operation, it also helps you to start testing immediately.
Will you accept credit card payments?
We accept all major credit cards to make purchasing parts or accessories as convenient as possible.
What type of customer support is provided?
Whenever you help we are here to assist. We offer support and training through teleconference, via proxy for software questions, or emails and phone calls.
Phone: 250-388-3531
Email: Support@vivitrolabs.com
Skype: ViVitro.Labs.Inc
Advanced Engineering Service
Can you modify equipment for an uncommon device design or test method?
Yes. Our advanced engineering department is adept at modifying and creating new test equipment. In today’s market, many devices are unique and pose their own set of testing challenges. We regularly modify our equipment to accommodate these unique designs. We have a pool of qualified vendors with unique offers to meet demanding equipment modification. Our expertise is used
Do you make custom test equipment?
Yes. We often create test equipment for custom applications. We have a pool of qualified vendors that produce hard to find or make components. Our own laboratory testing services and products development efforts provides us the expertise to understand your customer requirements. The value of understanding your testing requirements ensures your custom product will meet or exceed your needs. Time and cost is saved when the customer’s needs are perfectly understood from the start.
What is the engineering capability and capacity at ViVitro? V
iVitro fulltime engineers disciplines range from mechanical to software to fluid mechanics. We are well staffed and additionally supported by a team of 30-40 multi-discipline engineers at our on-site sister company StarFish Medical.
Can you provide custom software that is validated?
We have several software engineers that can create source code produced custom software. Forgoing the Labview / API style of data collection enables a fully validated software package. We provided clients with custom software that meets FDA-CDRH General Principles of Software Validation; Final Guidance for Industry and FDA Staff: 2002. With source code software, all elements of the software can be verified, tested and validated, eliminating the need for time consuming “black box” testing.
What are the requirements for validated software?
Under the FDA-CDRH guidelines, similar to other regulatory requierments, the Quality System regulation, clause 820.70(i), software used in production or as a part of the quality system must be validated. This regulation requires “confirmation by examination and provision of objective evidence that the particular requirements [for the intended use of the software] can be consistently fulfilled.” This requirement is to ensure that data produced by the software can be relied upon. The CDRH guidance document on software validation, states that “This requirement [in 820.70(i)]applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.” All software used to assess and/or document the safety and effectiveness of a medical device would fall within the scope of 820.70(i).
