When you work with us, your company will be getting more than just a service. We are an organization that specializes in providing cutting-edge training and consulting services for businesses looking to improve their overall efficiency through quality management systems implementation, including documentation maintenance, monitoring, and improvement.
Through years of experience in all aspects of medical device related processes, we offer you the benefit of understanding your company’s specific requirements and ensuring that your organization’s processes meet all applicable statutory and regulatory requirements. Our services also support your business goal of continued growth by increasing resilience within targeted markets for products you are responsible for designing, manufacturing, storing, servicing, selling, importing, or distributing.
MDR Consultants is a reliable, one-stop shop firm for all of your consulting and training needs.
Our mission is to raise the bar on quality, safety, and competence with a focus on patient safety so you feel confident in your ability to navigate the changing regulatory landscape. From consultancy services that deliver tangible improvements to the Quality Management Systems, outputs, and products or services offered by our clients, to cutting-edge training programs, our team has the expertise to guide you throughout every phase from design until aftermarket service calls have finished.
We understand that there are many different requirements for working in the medical device industry. That is why we have experts who specialize not only in the assessment, evaluation, and documentation against applicable requirements but also in their implementation. Our team comes from years of experience both inside QA/RA management positions at companies like yours, and as Medical Device Lead Auditors for Notified Bodies who in addition have successfully trained professionals in various roles on the most efficient and effective ways to ensure competence, conformance, and compliance to regulatory and statutory requirements. At MDR Consultants, we offer a wide range of services to help your company succeed in the medical device industry. Our consultants have 10 or more years of hands-on experience, with at least 5 as a Medical Device Lead Auditor for Notified Bodies, as well as extensive project management experience from inception through completion. Your experienced MDR Consultant is certified against applicable standards and regulations, and we proudly provide their certification and credentials upon request. We have the knowledge and expertise you need to create a Quality Management System that will meet or exceed industry standards. We help you meet these standards through assessment, remediation and implementation services that will allow your organization to stay up-to date with statutory and regulatory changes. Our deep understanding of the requirements for managing medical devices combined with MDR Consultant’s unique perspective informed by years of experience as Engineers, Lead Auditors and Certified Trainers for Notified Bodies, Consultants, and former members of industry has established MDR Consultants as a global leader in regulatory training and consulting services. MDR Consultants is well-versed in industry specific state-of-the-art standards and regulations of the medical device quality management system (QMS) to include but not limited to ISO 9001, ISO 13485, ISO 14971, UKMDR, MDSAP (Australia TG (MD) R & TG Act, Brazil Federal Law and RDC ANVISA, Canada (MDR) SOR/98-282 Part 1, Japan MHLW MO169 & PMD Act, US FDA 21 CFR 820), EU MDD, and EU MDR.
MDR Consultants was founded by Isabel Osorio, 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, a Certified Trainer for Notified Bodies, and as a 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 MDR Consultant’s mission to provide best-in-class training and consulting services.