Medical Device Clinical Evaluation Procedure Bundle

The Medical Device Clinical Evaluation Procedure Bundle includes 3 Standard Operating Procedures and related forms. The clinical evaluation procedure defines the process to plan, conduct and document a clinical evaluation, including post market clinical follow up. The clinical investigation procedure defines the process of conducting clinical investigations.  The post market surveillance procedure purpose is to establish, implement and update a post market surveillance system. All of the procedures and related forms are in MS Word or Excel formats. The medical device clinical evaluation procedure bundle complies with ISO 13485, MDR 2017/745, FDA QSR, and ISO standards or guidance documents referenced within each procedure.