Medical Device Regulatory Consulting
Common expected questions are whether a non-sterile medical device expected to perform transport validation? Is it mandatory to perform transportation test under laboratories? Alternative methods for transport validations. Transport validations are performed to examine the suitability of packaging compatibility and safety. The transportation and the storage must not affect the properties of medical device ie, …
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Do you know why medical device packaging is so important? Usually proper packaging is required by the medical device is to avoid, physical damage, biological contamination, and any other external disturbance. The other motive is the proper identification of the device. The medical device packaging validations are mostly required for terminally sterilized medical devices. Because …
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Definition of Medicinal Product: According to the second paragraph of Article 1 (2) of Directive 65/65/EEC provides the definition of the medicinal product, ‘Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in …
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Medical Device CE Marking 