Increase International Market Growth In Medical Market | GrowthMedics
The EU MDR aims to improve the safety of export medical devices by requiring manufacturers to carry out adequate clinical evaluation. The UKCA requires manufacturers to ensure that the design of the device is safe and will not compromise the clinical condition of the patient. This can be achieved through pre- existing data or a clinical investigation. The new Regulations also require manufacturers to assess the risk and benefit balance of their products.
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