Medical Device Inspection
The market for medical devices is growing rapidly over the years. As the medical device industry boom, both international regulations and government agencies that are related to the industry begin actively promoting revisions to current regulations on medical devices. As medical device products diversify and medical regulations grow more complex, manufacturer must be meticulous when choosing a reliable and professional research and testing company in order to ensure that products meets different nations’ requirements.
Terminally sterilized medical devices come in aseptic packaging and, before shipping out, are usually sterilized after packaging. To properly assess product’s post sterilization integrity and effectiveness, manufacturer should follow United States Pharmacopeia 71 and ISO 11737 guidelines to ensure no microbial contamination during product shelf life.Most medical devices come in sterilized packaging and, before shipping out, are usually sterilized after packaging. To properly assess product’s post sterilization integrity and effectiveness, manufacturer should follow United States Pharmacopeia 71 and ISO 11737 guidelines to ensure no microbial contamination during product shelf life.
Superlab not only offers general/regular testing for medical devices but also offers safety testing , functionality testing and contract research service to assist you in developing customized product. For more information, please refer to our contract research organization page or contact us.
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