Quality & validation digital healthlinor2020-08-12T10:15:40+00:00
Quality, GxP & validation in the digital health field
E-health & Digital health is a subgroup belonging to the field of Medical Device, which develops medical devices, accessories and software for patient needs (whether for home care or use in hospitals and clinics).
Because digital products of this type are used to treat, among others, sick people, this industry is exposed to high risk, and as such is characterized by stringent levels of supervision and regulation, to maintain public health, while minimizing the chance and risk of harm to human life.
The field of quality system management as reflected in ISO 13485, ISO 27001, ISO 27799 and the GDPR, MHRA, HIPAA requirements effectively govern all processes involved in the development, production and accessibility of digital healthcare products to end customers.
The quality industry in the medical industry in general and digital health in particular is characterized by a high level of dynamism. Health authorities’ quality requirements and guidelines are constantly updated and updated to provide patients and patients with reliable, accurate, sensitive, high-quality, safe and reliable digital products.
Apart from the strict management and quality assurance and control field, the digital health industry is characterized by innovative technologies, which include infrastructures such as the 5th generation of cellular networks, sensing, monitoring and control systems, DL, AI, ML and data analysis tools, and therefore should meet the ordination tests. Part of the certification process includes validation and validation (V&V).
Proper verification/certification / validation, alongside an effective and functioning quality management system, will improve the reliability, accuracy and performance of the digital product, and its quality and ensure that the product successfully meets both user expectations and requirements dictated by health and regulatory authorities throughout its life cycle. Of the product.