Assuming that your medical device must be sterile before application, it is included that sterilization is an integral part of your manufacturing process and as such subject to qualification and validation. The sterilization process is Always risk critical and as such the ISO 14971:2012 is applied. Depending on the methodology used for sterilization you have to follow the relevant EN ISO guidance (e.g. EN ISO 17665 in case of using an autoclave for sterilization.
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