Quality System Procedures According to the guidance, the authority expects the applicant to submit a copy of the quality system procedure(s) developed and implemented by the entity. The said procedure(s) should cover such aspects as: Quality audit or internal audit procedure(s); Management review procedure(s); Outline the structure of the quality system documentation. The requirement to [...]
The Health Sciences Authority (HSA), regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the change notification requirements for registered medical devices. The document is intended to provide additional clarifications regarding the interpretation of the applicable regulatory requirements, and also recommendations to be followed by the parties involved. At[.....]
The Food and Drug Administration (FDA or the Agency), has published a guidance document dedicated to the performance criteria for safety and performance-based pathway for facet screw systems. The document describes in detail the regulatory requirements such products should meet to be allowed for marketing and use in the US. It is important to mention[.....]