To to optimise their performance, companies in the medical sector need to ensure simple traceability of their entire production process in order to guarantee customer satisfaction.

The manufacture of parts in this field requires expertise in producing very small componentsThese are high value-added products produced in small batches. In addition, this sector is subject to compliance with strict standards such as ISO 13485 and CFR 21 Part 11.

The ISO 13485 standard is an international standard specific to the medical devices sector. It defines the requirements for a quality management system in order to ensure the conformity of medical devices throughout their life cycle, from design to production and distribution.

CFR 21 Part 11Title 21 of the Code of Federal Regulations Part 11 is a regulation issued by the US Food and Drug Administration (FDA). It establishes requirements for the use of electronic signatures and electronic record keepingThis is particularly true in regulated industries such as pharmaceuticals and medical devices.

This standard aims to guarantee the integrity, authenticity and reliability of electronic data used in regulated processes, while ensuring compliance with security and confidentiality standards.