Invetech’s in-house contract manufacturing offering, providing our clients with a single point of accountability throughout the entire product realization process. Our contract manufacturing teams deliver flexibility, IVD expertise, and quality products with ISO 9001 and 13485 certified manufacturing sites.
We have a long track record of successful IVD instrument manufacture for global diagnostics companies including Abbott, Bio-Rad and bioMérieux. Our manufacturing processes, quality procedures, production tools, logistics systems, operator training and resource management are precisely customized to perform in the constraints of the IVD domain.We provide a flexible set of manufacturing solutions for each step of the product lifecycle and any business case, from prototyping and small batch production, to pilot production lines and full-volume production.
We have manufacturing facilities in the United States and Australia. We are FDA registered 3015046612 and are certified to ISO 9001:2015 and ISO 13485:2016
Our manufacturing mindset begins very early in the product development process with our in-house contract manufacturing engineers joining the core project team. Their role is to ensure the manufacturability of the products we are designing which results in a more cost-efficient manufacturing strategy and helps accelerate the transition to manufacture. To further enable team collaboration, our engineers are trained in design for manufacture (DFM) tools such as the 3P process, DFMEA/PFMEA and critical component management.
Having integrated design, engineering and manufacturing teams leads to increased efficiencies and minimizes risks for our clients throughout the entire product development lifecycle. Utilizing one team with already established communication channels, standardized documentation formats, and shared processes and systems significantly reduces the ramp-up time for a more seamless transfer to manufacturing.Furthermore, our manufacturing team continues to have rapid access to the design team during process Validation and scale-up. This enables us to resolve issues sooner and get your product to market faster.
As a former Danaher and Fortive company, our learned Business System is part of our organizational DNA. Adapted from the famed Toyota Production System, our Business System is a framework focused on continuous improvement, customer-centric processes, visual management and Lean manufacturing. All Invetech employees are trained in the tools of our Business System which are designed to eliminate waste, minimize risk, ensure on-time delivery, promote safety and, on the highest level, provide a superior experience to our customers. We use these proven tools and processes to continuously improve quality and on-time delivery for our contract manufacturing clients.
It is our mission to take care of the manufacturing of the instrument with both autonomy and transparency so our OEM clients can focus on taking care of their end users, reagents and product distribution. We’ve won multiple supplier awards from some of the top IVD OEMs because of this approach. Our partnering services are managed by a dedicated product manager who leverages our Business System tools for visual and daily management to provide “at a glance” knowledge of key metrics. Product sustaining services include forecast and planning, sustaining engineering and component obsolescence, as well as quality management and tracking.