Day 1

According to a MassDevice news article titled 8 medical device companies that beat the COVID-19 pandemic and prospered, “Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’ spread.” Medical device companies that create products must remain in alignment with industry standards like ISO 13485 and IEC 62304 for development and ISO 14971 for risk management. Focusing on an infusion pump use case, you will learn the phases of (1) design planning, (2) product requirements and risk management, (3) design input and (4) design output for developing a medical device.