White Paper Download: "5 Essential Steps To Medical Device Certification"
The medical device industry relies on a higher level of documentation records than many other certification categories. It is important -- especially for start-up companies -- to consider that developing a functional prototype is NOT sufficient to meet the full regulatory burden. It is critical to generate all the documentation that covers the key elements of the IEC 60601-standard series, Food and Drug Administration (FDA) guidance, the Medical Device Regulation of Europe (MDR), and more.