Quality Assurance
Quality assurance extends throughout all functions in Vitalograph for greater company efficiency and continuous improvement of product and customer service. We have implemented systems to meet relevant Clinical, Data, Management, Training, Design, Manufacturing, Distribution and Service requirements. For information on particular product standards, please see our product pages
FDA 21 CFR 820
21 CFR Part 820 is intended to ensure devices entering the US marketplace are safe and effective. Vitalograph complies with the regulation and has registered devices that are for sale in the US. Compliance is monitored by the FDA, with yearly onsite audits.
ICH – GCP E6
International Conference on Harmonization (ICH) GCP guidelines provide internationally accepted ethical and scientific guidance covering the design, conduct, recording and reporting of clinical trials, to ensure safety of subjects, the integrity of trial data, and that the conduct of trials is carried out in conformance to Good Clinical Practice (GCP).
ISO 13485
ISO 13485 specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices. The requirements given in this standard are applicable to Vitalograph in the design, manufacturing, distribution, installation, provision of training, support, servicing and post market surveillance of all our medical devices including software.
Medical devices have special requirements over and above consumer products for safety, performance, and efficiency; processes associated with these requirements are covered in this standard to ensure full product safety, reliability and traceability, starting with the design process, through to their use on patients/subjects, and subsequent device disposal.
ISO 27001
Vitalograph adopts recognized best practices where they may benefit customer and/or our business model. ISO 27001 is an example of such standard.
ISO 9001:2015
Sale and distribution of respiratory diagnostic medical devices and consumables to healthcare and provision of solutions and services to clinical trials of respiratory medicines.
Vitalograph has bs been assessed and certified as meeting the requirements of the ISO/IEC 27001:2022 Information Security Management System