The manufacturing of small or medium numbers of medical and IVD devices meeting high regulatory and documentary requirements is no problem for the experts at Mechatronic.
We transfer the designed device directly into our manufacturing process and also smoothly transfer the whole manufacturing itself from a given location to ours.
On a 1,000 square-meter space we assemble and test our customers’ devices under ideal conditions.
At our site in Höhn (situated in the Westerwald region), requirements based on norms and regulations such as ISO 13485, ISO 9001, FDA, CSA, CCC, Anvisa, UL, and VdS are dealt with. From here, we deliver devices worldwide.
Customer audits regularly confirm the excellent compliance and performance of our production site.
With the help of an integrated ERP solution, we consistently monitor processes of disposition, procurement, production, and supply. We keep the corresponding digital documentation safely for our customers (FDA Part 11 compliant).
What this means: high-level manufacturing – close to home and reliable.
