Our Quality Management Support is an unparalleled service designed to help you adapt your existing quality management system in accordance with the key regulations world-wide, such as ISO 13485, EU MDR 2017/745, RDC 665/2022, 21 CFR 820 and others.

As a standard-bearer in the field of medical device regulatory affairs, Sobel Consultancy's experts conduct comprehensive internal audits that provide an in-depth view of your current compliant status. With our extensive experience, we identify and implement the missing pieces needed to ensure your quality management system fully complies with requirements that your company needs.

This service also includes assistance in communicating with regulatory agencies (FDA, ANVISA, Notified Bodies), an essential aspect many find daunting. With Sobel Consultancy at your side, you'll never have to navigate these complex conversations alone.