- Why Us
Starting off with the right foundation to develop high-quality devices is challenging. It’s easy to lose sight of creating a culture that values excellence and quality when you’re juggling funding, regulatory, design, product development, laboratory procedures, growing markets, competitors, and rapidly growing technology. All these areas can become roadblocks if not managed properly in an end-to-end system.
Whether you are submitting to the EU, FDA, Health Canada, or others, your path to market and steps to success are determined by your classification and requirements that follow. Getting started with a world-class QMS tailored to your device type is the best way to align with regulatory guidelines.
Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.
A free, in-depth webinar covering the medical device classification system and how companies can use it to their competitive advantage by using best practices for ...