Quality Validation & GxP in Medical DeviceYaniv2020-09-15T19:12:55+00:00
Quality Validation & GxP in the Medical Device filed
Medical Devices are being used to treat, diagnose, and cure, and as a result, pose a high risk to patients. This is the main reason why the medical device industry is characterized by stringent levels of supervision and regulation. The main target of the Quality Management System, SOPs training, verification and validations, is 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, GDPR, MHRA and HIPAA requirements that effectively govern all processes involved in the development, production and accessibility of medical device to end customer and physicians.
Health authorities’ quality requirements and guidelines in the medical device industry are constantly updated to provide patients and doctors with reliable, accurate, sensitive, high-quality, safe and reliable medical devices. 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 medical device, 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.