A Closer Look at the Real Impact of Recalls
A recent recall event illuminated a staggering truth: a recall can cost a company over a billion dollars. However, when we take a moment to truly understand this information, we realize that the real cost isn’t solely financial. The human suffering and impact that those billions of dollars represent are immense and often go unacknowledged.
My Journey in the Medical Device Industry
With over 18 years of dedication to the medical device industry, including six years as a lead auditor for notified bodies, I chose biomedical engineering with a single purpose: to help people. Our industry often intersects with lives at their most vulnerable moments—when individuals are sick and in desperate need of accurate diagnoses, effective treatments, and healing. Every medical device we create is expected to perform its intended function flawlessly.
Our Duty to Ensure Safety and Quality
Given the profound impact our products and services have on human lives, it is our duty to mitigate risks and ensure our quality management systems (QMS) are both effective and consistently implemented. This stability is crucial for producing products that reliably meet the stringent requirements of our industry.
The Power of Audits in Maintaining Standards
One of the most powerful tools we have for maintaining high standards is our internal audit process, along with audits of our critical vendors. The depth, time, planning, and quality of resources dedicated to this process always yield a significant return on investment, ensuring that we meet and exceed the necessary standards for safety and effectiveness.
Our Expert Team
Throughout my career, I have had the privilege of working with some of the most talented and knowledgeable QA/RA experts in the industry. Many of these professionals are now part of my team. If my areas of expertise do not fully meet your requirements, I will ensure that the audits are performed by the best professionals in the field. This is my personal warranty to you.
Partner with Us
Allow me to bring my 18 years of experience in the medical device industry to your organization. Let me be your eyes, assessing your Quality Management System (QMS) and your vendors’ QMS with the same diligence I employed as a certified lead auditor. Together, we can determine your level of compliance and conformance to applicable requirements, ultimately helping to reduce potential human impact.
MDR Consultants Inc., your Medical Device Regulatory and Statutory Experts.
Contact Us Today!
Partner with MDR Consultants Inc. to ensure the highest standards of safety and quality in your medical devices, protecting not just your business but the lives that depend on your products.
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 info@mdrconsultants.com