Hard Skills
AdvancedMedical Device Design ControlThe application of a formal process to control the design of a medical device to ensure it meets user needs and intended uses as per ISO 13485 or FDA 21 CFR 820.30.
IntermediateBiocompatibility AssessmentEvaluating the biological risk and compatibility of materials used in medical devices according to ISO 10993 standards.
AdvancedRegulatory Submission StrategyThe ability to prepare and navigate regulatory pathways such as 510(k), PMA, or CE marking for the commercialization of biomedical technologies.
IntermediateComputer-Aided Design (CAD) for Biomedical ApplicationsUsing specialized software like SolidWorks or AutoCAD to create detailed models and prototypes of medical components and prosthetics.