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Quality Management Support

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.

Why do you need this service?

The conduction of internal audits will shed light into your existing compliance status. This helps to define the exact resources need to close these gaps.

Our experts will support in implementing the required measures to comply with key regulations. Independent if you already have already an existing quality certificate. We adapt to what is actually required. You invest only what is really needed.

You talk with your competent authority and don't understand what they are requiring? Our experts, with many years of equivalent experience, can help. We speak the language both sides can understand.

Looking for quality management assistance?

Ensure your Quality Management System is fully compliant. Our team of experts conducts comprehensive internal audits, identifies gaps, and implements essential changes, making the compliance process seamless for you. We even assist with challenging conversations with competent authorities. Why wait?

Partner with Sobel Consultancy and make your journey a successful one.

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