Medical Device Regulation - Quality Management Support​

Experience risk management like never before with our ISO 14971 based Risk Management Support for medical devices. This comprehensive service promises to navigate the intricate matrix of risk management, ensuring your medical devices meet industry standards and exceed user expectations. Our team of experts collaborates closely with yours, ensuring all required activities are meticulously planned and executed.

Starting with a thorough risk analysis, we delve deep into potential pitfalls and challenges. Our experts work alongside your team, not only identifying risks but also evaluating them against the backdrop of the healthcare sector's ever-evolving landscape. They pinpoint the most effective control measures, leading to a robust and resilient risk management strategy that leaves no stone unturned.

Once the analysis is complete, our expertise doesn't end there. We compile an exhaustive risk management report that encapsulates the entire process and its results. This detailed report offers an insightful evaluation of the overall risk, equipping you with knowledge and understanding to make informed decisions.

With our Risk Management Support, you gain control over potential risks, elevating your medical devices' safety and efficacy. It's not just about meeting ISO 14971 standards; it's about surpassing them. Trust us to guide you through the labyrinth of risk management, ensuring peace of mind and a secure path to success in the medical device industry.

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 the MDR 2017/745. 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 Notified Body and don't understand what they are requireing? Our experts with many years of equivalent experience can help. We speak the language both side 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 Notified Bodies. Why wait? Partner with Sobel Consultancy and make your journey towards EU MDR compliance a successful one.

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