Quality management
Operating processes and quality management systems
AKERN® has been developing medical solutions dedicated to body composition since 1980.
Our Quality Management System, structured in compliance with ISO 9001 and ISO 13485, guarantees continuous improvement to all of our processes, products and services.
ISO 13485 in particular establishes a “quality system for medical device manufacturers” and these complex regulations cover different aspects: from the design to post-launch activities and services to the manufacturing process, traceability and safety checks that are conducted on all of our devices.
Every single device for bioimpedance analysis produced by AKERN® undergoes a double quality control: the first one upon leaving the production site and again at during certification. All documents related to these validations are stored for a minimum of five years.
Quality control covers all aspects, from regulatory affairs to operational processes and is part of an integrated system created with the aim of eliminating any potential risks related to use of the medical device, and to constantly increase performances.
During the manufacturing process, AKERN® relies on qualified and certified suppliers , and whenever possible, favors local producers for the components and raw materials.
One other important task of AKERN®’s Quality management system is the traceability of the devices and their critical components. The entire production and distribution supply chain is traceable through serial or batch numbers that enable the fast and precise identification of the components presenting issues or malfunction, in terms of safety, or integrity and quality performances. All devices undergo electromagnetic compatibility and electrical safety tests. Most recent devices also undergo specific stress tests during the design stage to verify reliability.
AKERN® is renowned for its quality standards. Our quality standards guarantee constant monitoring of our products and services and this commitment is stated in our corporate quality policy document.
Company compliance
AKERN®, leader in the body composition field, is committed to compiling with the highest ethical standards thus respecting all laws, regulations, codes and company procedures to which our activities and corporate policy refer to.
For anyone wishing to report any violation to the compliance, a dedicated email address is available: regulatory@akern.com.
Certifications
All AKERN® solutions are certified CE MEDICAL DEVICES. AKERN® devices are designed and produced in Italy and are certified as Class IIA medical devices, in accordance with Directive 93/42 EEC as amended since 1998.
AKERN® controls every step of the production and distribution chain and has chosen to adopt the highest standards for the certification process, working with the notified certification body Bureau Veritas.
