Safeguarding Innovations: Mastering FDA and ISO 14971 Standards with MDR Consultants

At MDR Consultants, we recognize the rigorous processes that steer your medical innovation journey, particularly when it comes to risk assessment for medical devices. Our robust network of experts specialises in flawlessly navigating the technicalities involved, making us an indispensable partner in your voyage.


Guiding you through the rigorous standards of FDA medical device protocols, we pride ourselves on our meticulous approach and up-to-date knowledge of the regulatory landscape. This stringent vetting process ensures your product complies with critical safety and performance standards, reinforcing consumer trust and preserving your brand’s reputation.


As we embark on this journey together, our commitment to ISO 14971 risk management becomes our guiding star. We diligently apply this internationally recognized standard for risk management to every project, ensuring you are always ahead in the market. This standard not only fosters consumer trust but also shields your organisation from potential liabilities and risks.


Moreover, here are three compelling reasons why partnering with MDR Consultants makes sense:


  • Experience: We have an impressive track record of guiding medical device manufacturers through complex regulatory landscapes.
  • Comprehensive Approach: Our end-to-end solutions cover everything, from initial product conceptualization to final market approval.
  • Dedicated Support: Our team remains committed to you throughout your product’s lifecycle, providing continuous support and guidance.


Our goal at MDR Consultants is not just about helping you navigate these protocols; it’s about establishing a trusted partnership that propels your medical innovation to new heights, enabling you to deliver cutting-edge, reliable, and safe solutions to those who need them most.


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About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at