30 years and thousands of samples after opening, Dynatek Labs has often found that the unique features of your stent, heart valve or other cardiovascular (CV) device may not lend themselves to an off-the-shelf testing solution. In fact, while AAMI/ISO, FDA and ASTM regulations spell out the objectives of the test, developing an appropriate test, test fixture or test protocol for unique cardiovascular devices can be very challenging even for established cardiovascular companies.
Range of Custom Services to Meet Your Requirements
• Custom testing solutions and platforms
• ‘Heavy lift’ capability for growing companies
• Customized accessories for existing machines
Dynatek has been building custom test equipment for our own requirements and have assisted virtually every major CV device manufacturer in the world with their regulatory requirements. Whether you need a customized accessory for an existing tester or a fully-customized test solution for your CV device, Dynatek has an extensive breadth of capabilities that can turn your testing challenge into a cost-effective custom solution.
From Innovation to Custom Solutions
Dynatek’s custom solutions meld innovation, imagination, engineering excellence and a deep knowledge of the regulatory envelope. We know what your risks are; we know that ‘time to market’ really means millions of dollars to you, and no one has been testing CV devices longer than we have.
A leading international CV device company working under an aggressive deadline, needed to design a test protocol and submit their unique device for regulatory approval.
No existing test platform could test their device and they turned to Dynatek for help. Dynatek developed a custom testing concept, rapidly developed an engineering design and fabricated the test platform in record time. Result: the company met all their testing requirements and were so impressed by Dynatek’s capabilities that they ordered a second test platform to accelerate their testing schedule
Build Your Testing Capacity by Partnering with Dynatek!
Startups and growing companies are often resource-strapped. By partnering with Dynatek, we can do the ‘heavy lifting’ for you, whether it is with custom solutions, or rapidly tooling up to provide multiple test platforms to test a large number of samples to meet tight deadlines.
“…our CV device was unlike anything the market had seen before, and quite frankly, we didn’t know where to begin with our test protocol. So we decided to go with Dynatek, and they delivered!”
A heart valve company wanted to test 60 heart valves for regulatory submission under a very tight deadline. Acquiring instruments, hiring staff, training and testing would be cost- prohibitive and take too long. Instead, they decided to partner with Dynatek. We built a battery of M6 Heart Valve Testers to start their testing and were ready one week after the order was placed.
In effect, the heart valve company had created a full-fledged, high-capacity, world-class testing lab capable of hitting the ground running at a fraction of the cost and time needed to replicate one at their facilities.
We can work from a SolidWorks drawing of your device or a hand-drawn diagram on plain paper. Our services range from design, prototyping, and proof of concept to development of the tester/test protocol, using over three decades of experience and expertise in the medical device testing market.
For your next custom testing project, try Dynatek. We know you will be delighted!