In the highly regulated medical device industry, internal audits are essential for ensuring compliance with FDA Quality System Regulation and ISO 13485 standards. However, conducting a thorough and objective internal audit can be a challenging task, especially for companies with limited resources and expertise. That’s where a Medical Device Internal Audit Consultant can make all the difference.
A Medical Device Internal Audit Consultant is a professional with extensive knowledge and experience in FDA Quality System Regulation and ISO 13485 consulting and internal auditing. They are typically independent contractors who work with medical device companies to assess their quality management systems (QMS) and identify areas for improvement.
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