ViVitro labs works closely with customers to define their requirements for custom medical device testing equipment. An expert in testing cardiovascular devices, we help bring many “un-written” requirements into the final design to ensure the tester exceeds expectations. It is important to note that any engineering work conducted as part of an equipment customization does not require compliance with ISO 13485 or ISO 17025.
The customization process may start with an initial feasibility study in our laboratory. This allows for a fast and cost effective proof of concept to be developed. Depending on the complexity of the tester, initial prototypes may be made from fast manufacturing processes such as 3D printing, bread boards, and LabVIEW software. Once this functionality is confirmed final machined parts, PCBs, and software can be fabricated and tested. ViVitro Labs uses a rigorous verification and validation process to ensure designs meet user requirements. Support can also be provided with the system including user manuals and on-site training. Custom medical device testing equipment can be designed for any budget for companies at any stage of development, these can be working prototypes to polished turn-key solutions. ViVitro is able to change and adapt the custom testing equipment as a company and design mature.
ViVitro utilizes our in-house industry experts, resources from our parent company, StarFish Medical, and external consultants as required to meet the constraints of a particular custom medical device testing equipment. ViVitro products are designed to be highly versatile and have been used in many different applications to test a wide range of medical devices. Read more here how ViVitro equipment and customized solutions have helped these cardiovascular pioneers achieve their goals.