Medical
The Challenge
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.
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 11, or Title 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 the electronic retention of records, particularly in regulated industries such as pharmaceuticals and medical devices. The standard aims to guarantee the integrity, authenticity and reliability of electronic data used in regulated processes, while ensuring compliance with security and confidentiality standards.
Thanks to Ellistat's softwareYou'll be able to meet many of the requirements of ISO 13485 and CR21 Part 11:
Detecting non-conformities
Measurement control and attribute control to monitor batch acceptance
Compliance with CFR 21 part 11
Carrying out regular checks to ensure the authenticity, reliability and validity of digital data processing systems.
Read our case studies on the deployment of ELLISTAT within the Medical sector
"In my opinion, if you want to optimise control efficiency in your company, the only software solution to use is Ellistat. This is thanks in particular to the artificial intelligence built into the software, which enables only what is necessary to be controlled automatically. If I had to do it all over again, I'd go back to Ellistat" - David Scarpino, Co-Managing Director of Bien-Air Surgery
"Today, the Azurea group has 60 APC licences, one per machine. Vincent Skrzypczak comments: "All you have to do is measure the part, enter the data into APC and it automatically makes all the corrections at once. This makes the work of our employees much easier.
Compliance of Ellistat software with CFR21 part 11
The American standard 21 CFR Part 11 defines criteria to provide a legal framework and the same evidential value for electronic signatures on digital documents as for handwritten signatures on paper. It requires regulated companies to carry out regular checks to guarantee the authenticity, reliability and validity of their digital data processing systems.