Gentian Heath has the expertise to both design and manufacture larger-scale medical and analytical laboratory instruments.
In many cases, these systems are used in conjunction with the single-use devices developed by our medical device design and manufacturing team.
Gentian Health’s cross-functional design team works with its clients to develop and manufacture bench top and trolly based laboratory instruments which involve a combination of complex electronic and mechanical design.
Stand-alone analytical lab instruments require a combination of custom and off-the-shelf electronics, various sensor technologies, touch screens and user interface technology all combined in a system with either metal or plastic enclosures.
Design for manufacture and early-stage manufacturing process design are layered in at each stage of the product development lifecycle ensuring that the first batch of analytical lab instruments built for clinical trial is representative of full-scale manufacturing and is suitable for all clinical and regulatory activity.
Our analytical lab instruments are designed and manufactured with extreme precision and the highest quality standards. Gentian Health provides full Design V+V and Design history file along with process validation documentation and device history records for Clinical trial and follow on manufacturing batches.