The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s agency responsible for the assessment of quality and safety of medical devices, has published an official notice describing the updated rules on a temporary suspension of...
The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to personalized medical devices. The document provides additional clarifications and recommendations regarding...
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and healthcare products has published an action plan on Software as a Medical Device (SaMD) based on the Artificial Intelligence / Machine Learning (AI/ML)...
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the off-label use of medical devices. The scope of the guidance covers only the medical devices...
Please fill out the form below and one of our team members will get back to you as soon as possible!
Request A Demo
Please fill out the form below and one of our team members will get back to you as soon as possible!
We use cookies to understand how you use our site and to improve your experience. By continuing to use our site, you accept our use of cookies. Find out more.