The Quality and Regulatory Department works to ensure compliance with the standards and regulatory requirements, from design to commercialisation of our medical devices.
In2Bones is ISO 9001 and ISO 13485 certified
Manufactured products are CE marked, in accordance with the recommendations of directive 93/42/EEC, amended by directive 2007/47/EEC.
We take into account the requirements of users (surgeons, nurses, etc...) and optimise the processes for placing products on the market.
Our suppliers are selected, supported and evaluated continuously in order to ensure quality and the consistency of reproducibility of our output.