18/08/2023
In a world where healthcare is evolving at an unprecedented pace, the design and development of medical devices demand meticulous attention to detail. The European Union’s Medical Device Regulation (EU MDR) 2017/745 has set new standards for the industry, requiring manufacturers to adhere to a systematic approach that ensures safety, efficacy, and compliance. In this guide, we’ll walk you through the steps of designing and developing a medical device under the EU MDR using the Waterfall process. We’ll also introduce you to SmartEye, an advanced eQMS software that can revolutionize your product lifecycle management.
In a world where healthcare is evolving at an unprecedented pace, the design and development of medical devices demand meticulous attention to detail. The European Union’s […]