EU MDR 101: Introduction, Overview, and Implementation Process of the EU MDR (2017/745) Online Course
Learn why the change from a Directive to a Regulation has created massive shifts across the industry, what it means for your unique role, and how to start the transition now with confidence to avoid the serious consequences of nonconformance.
Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market
The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:
Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market
The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:
Hi, I’m Isabel Osorio
I have the unique experience of having worked as an Engineer, Lead Auditor and Certified Trainer for Notified Bodies, Consultant, and former member of industry throughout my 16 year career in the MDR field.
I’ve created a course called Introduction, Overview and Implementation Process to the EU MDR (2017/745) as a comprehensive training that covers everything required to have a strong foundational knowledge of all the changes. Rather than feeling overwhelmed and frustrated, you will feel confident and prepared to navigate the transition to the new regulatory requirements.
Hi, I’m Isabel Osorio
I have the unique experience of having worked as an engineer, auditor and as a member of industry throughout my career. I’ve been a consultant since 2019.
I’ve created a course called Introduction, Overview and Implementation Process to the EU MDR (2017/745) as a comprehensive training that covers everything required to have a strong foundational knowledge of all the changes. Rather than being annoyed and frustrated, you will be confidently prepared to navigate the transition to these new regulation requirements.
Understand EU MDR (2017/745) so you can ensure products are compliant from phase one of design.
If you sell or plan to offer medical device products or related services in the EU, this course is for you.
Any company or individual with a role in supply chain management, import, export, distribution, and logistics related to products sold in the EU.
Professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles.
EU MDR 101 is the only online training course designed from the unique perspective of an EU MDR Certified Trainer with experience as a Biomedical Engineer, Lead Auditor for Notified Bodies, Consultant, and a former member of industry.
By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to ensure your Quality Management System and resulting products are compliant and conformant to the EU MDR (2017/745) regulation.
Practical Tools
We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.
Real-world Perspective
Isabel Osorio has the unique perspective of having experience both as an engineer AND an auditor. This means we teach exactly what systems you need in place in order to successfully pass an audit (and how to make them more efficient and less resource-draining).
Reimbursement Opportunities
Also, be sure to ask your employer for opportunities of reimbursement. You may qualify to take the course at no cost to you.
By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to implement proper quality test to ensure your devices are compliant and up to code.
Practical Tools
We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.
Real-world Perspective
Isabel Osorio has the unique perspective of having experience both as an engineer AND an auditor. This means we teach exactly what systems you need in place in order to successfully pass an audit (and how to make them more efficient and less resource-draining).
Reimbursement Opportunities
Also, be sure to ask your employer for opportunities of reimbursement. You may qualify to take the course at no cost to you.
Maybe you have colleagues who have taken a course on this topic and were still unclear on it all. That won’t happen with this course.
EU Legal Framework
EU Legal Framework
Introduction, Overview, and Implementation Process to the
EU MDR (2017/745)
Introduction, Overview, and Implementation Process to the
EU MDR (2017/745)
Stay ahead of the curve and certify your competence in the updated EU MDR regulation (2017/745).