Process Validation
Process validation means establishing objective evidence that a process consistently produces a result or product that meet its predetermined specifications.
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Transport Validation
Transport validations are performed to examine the suitability of packaging compatibility and safety. The transportation and the storage must not affect the properties of the medical devices i.e, the device must be damage free, maintain sterility, no physical damage, no biological contamination and function as intended.
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Risk Analysis
Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which may be encountered in connection with the use of a medical device. Manufacturers are expected to identify possible hazards related with the design in both normal and fault conditions. If any risk is identified as unacceptable, it should be reduced to acceptable levels by appropriate means. To control risk there is term called as Risk Control.
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Medical Device Labelling
Medical Device Labelling is the means to communicate information related to the safety and the performance of the device to the users which includes the proper identification of the device or group of devices too. It helps the end user to use the device as intended by the manufacturer.
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