We help you in determine General Safety and Performance Requirements (GSPR) for your Medical Devices as per the EU MDR and EU IVDR compliances in Vietnam, Malaysia, Hong Kong and Thailand. General Safety and Performance Requirements (GSPR) are standards established by various global regulations like USFDA, EU MDR and IVDR that specify the safety and performance criteria that must be met by a product or service before it can be sold or used. These requirements are necessary to ensure that a product or service is safe to use, performs as expected, and meets the needs of the consumer.
