Are you ready for the Clinical Laboratory Improvement Amendments waiver? With the large market for laboratory devices growing fast, the benefits of designing for the waiver are even more important for better and faster patient care.
For manufacturers, it vastly broadens the potential market to include non-lab and non-hospital clinics, urgent care centers, medical facilities with a Certificate of Waiver and even home care. For patients and providers, it improves patient care by streamlining urgent testing with access to near-immediate test results for in-office diagnosis and treatment.
Learn more about how our team is equipped to support CLIA-waived device design efforts with years of experience designing simple and accurate devices that meet the waived-test criteria set forth by the FDA.
Tensentric is a team of highly experienced engineers developing a wide range of medical devices and in vitro diagnostic systems. Tensentric has completed over 300 development projects for clients in the medical device and IVD space since the company’s inception in 2009 and is ISO 13485:2016 certified for design and manufacturing. With capabilities for BSL-2 lab use, manufacturing process development, rapid prototyping, human factors validation and consulting, and in-house design for injection molding expertise, Tensentric is uniquely suited to a wide variety of medical device design, development, and manufacturing application.