Quality Management

In today’s world, quality of a product is not measured just by its appearance but by the safety, it provides to the patient. Cardic Instruments therefore maintains an environment in which every single staff member is motivated to ensure first-class product quality, best functionality & consistent process reliability.

Our workforce is trained to perform every step of production in such a manner that guarantees perfect results with complete traceability. Constant checks during manufacturing and at the end of a production process also ensures a long service cycle.

The QA team of Cardic regularly updates our documentation & policies to make sure that we comply with the latest international regulations.

Our quality management system is currently certified in accordance with the following standards:

  •     ISO 13485 : 2016
  •     ISO 9001 : 2015
  •     Directive 93/42/EEC, Annex I
  •     MDR 2017/745 (certification planned for 05/2022)
  •     Different national regulations, e.g. FDA, CFDA etc.