ISO 13485 Certified

The Cromatek strives for excellence in all its production processes, that's why we're looking for certification ISO 13485 an international standard that defines the requirements for a quality management system for medical devices.

This certification guarantees that these devices meet the requirements and are safe and effective for their intended use. Implementing the standard demonstrates our commitment to maintaining the safety and quality of all stages in the assembly of a medical device. This includes the necessary raw materials, production, storage and distribution.
It also has a greater emphasis on risk management and decision-making, as well as changes related to the increased regulatory requirements for organizations in the supply chain, both in the procedures carried out by the company and in the infrastructure.

We are thrilled to say that we are in the process of implementing ISO 13485,we are committed to the continuous improvement of our processes, ensuring that we are always at the forefront of technology and innovation in the medical device industry. We are excited about the opportunities this certification will bring to our company and our customers.