Quality Assurance and Regulatory Affairs

Quality Assurance and Regulatory AffairQuality is the most important ingredient in customer satisfaction. To meet all of our customers’ expectations, we will focus our efforts on providing high-quality products and services through innovative design and state-of-the-art manufacturing, while diligently maintaining the effectiveness of our quality system and full compliance with Food and Drug Administration (FDA) and ISO 13485 requirements.

The regulatory aspect of the company is operated by a highly qualified team that adds depth and knowledge to their role at K2M. Please feel free to browse these pages to familiarize yourself with some of K2M’s regulatory accomplishments.