Hi Isabel
Krystal and I really enjoyed your course today. We will make sure to answer the survey once it's received.
Thank you for your time.
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:
- If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be placed on the market.
- If you have Class I devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and product's technical documentation needed to meet the new EU MDR requirements as of May 26, 2021.
- If new products are launching, they are not covered by the MDD and therefore need to be conformant to the EU MDR.
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:
- If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be place on the market.
- If you have Class 2 devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and documentation system needed to meet the new EU MDR requirements as of May 26, 2021.
- If new products are launching, they are not covered by MDD
70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?
Here's just a few reasons:
- They think that implementation can be completed in just a couple of months because they don't understand the magnitude of the regulation's impact on their day-to-day
- They're overwhelmed by the sheer amount of information and complex provisions
- Confused about where to begin
- Skeptical of the expertise of training instructors
- Insecure about their current level of knowledge regarding the regulation.
But we're here to make it easy for you.
70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?
Here's just a few reasons:
- They're overwhelmed by the sheer amount of information and complex provisions
- Confused about where to begin
- Skeptical of the expertise of training instructors
- Insecure about their current level of knowledge regarding the regulation.
But we're here to make it easy for you.
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.
Who Is This Course For?
Engineers
Understand EU MDR (2017/745) so you can ensure products are compliant from phase one of design.
Members of Industry
If you sell or plan to offer medical device products or related services in the EU, this course is for you.
Supply Chain Management
Any company or individual with a role in supply chain management, import, export, distribution, and logistics related to products sold in the EU.
Quality Assurance (QA) & Regulatory Affairs (RA) Personnel
Professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles.
When it comes to competence, course delivery and trainer experience matters.
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.
We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.
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.
We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.
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.
Even if you understand the importance of starting now, you also don’t want to waste money on a subpar course
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.
What We Will Cover:
EU Legal Framework
Quality Management System Requirements
Risk Classification
Conformity Assessments
General Safety and Performance Requirements
Technical Documentation
What We Will Cover:
EU Legal Framework
Quality Management System Requirements
Risk Classification
Conformity Assessments
General Safety and Performance Requirements
Technical Documentation
Introduction, Overview, and Implementation Process to the
EU MDR (2017/745)
Course Outline: EU MDR 101
Introduction, Overview, and Implementation Process to the
EU MDR (2017/745)
Course Outline: EU MDR 101
EU legal framework
- Entry into Force and Date of Application
- CE Marking Requirements
- EU Market Product Release Process
- Legal framework on Release of Regulation 2017/745
- UKCA mark
- Structure of the Regulation
- European Commission Objectives
- Top Level Review of the Regulation
- Responsibilities
Scope
- Intended Purpose
- Definition of Medical Device
QMS
- Quality Management System Requirements
- ISO 13485
- ISO 14971
- Language Requirements
- Commons Specifications and Standards
- MDCG Guidance Documents
- Strategy for Regulatory Compliance
- Competence of Persons and Authors
- Liability Insurance
- Certificate of Free Sale
Risk Class
- Device Class
- Device Risk Classification
Conformity Assessment
- Pillars of Technical Documentation
- Conformity Assessment
- Routes to Conformity
- Quality System Based Assessment Annexes
- Product Based Assessment Annexes
- Assessment Route Considerations
GSPRs
- General Safety and Performance Requirements
- General Requirements
- Types of Information Supplied with the Device
- Clinical Evaluation
- Clinical Investigations
- SSCP
Technical Documentation
- Content and General Requirements
Apply
- MDR Designated NBs and MDR Codes
- NB Conformity Assessment
- Additional Procedures
- Certificate Scope
- SRN, UDI, EUDAMED
Marking
- DoC and CE Marking
PMS+
- Post Market Surveillance and Updates
- Post Market Surveillance
- PSUR
- Post Market Reports
- Plans needed under the MDR
- Vigilance
- Actions of Competent Authorities after Report
- FSCA and FSN
- Grace Period and Significant Changes
PMS+
- Post Market Surveillance and Updates
- Post Market Surveillance
- PSUR
- Post Market Reports
- Plans needed under the MDR
- Vigilance
- Actions of Competent Authorities after Report
- FSCA and FSN
- Grace Period and Significant Changes
People are praising EU MDR
What makes them love us?
Jasmin
Isabel
We appreciate the information. It sure gives us a clear picture of addressing the complexities of the new regulatory environment under EU MDR.
Thank you
We appreciate the information. It sure gives us a clear picture of addressing the complexities of the new regulatory environment under EU MDR.
Thank you
Chris
Hi Isabel
I appreciate all your help these past few weeks. Its been a great help in preparing us for the audit this week.
Best regards,
I appreciate all your help these past few weeks. Its been a great help in preparing us for the audit this week.
Best regards,
Noemi
Director, Quality Systems
EU MDR 101 brings this complicated topic to life with real life examples from a former member of industry so you can plan your implementation with confidence.
Stay ahead of the curve and certify your competence in the updated EU MDR regulation (2017/745).
FAQ's
- RA, QM, and QA professionals
- Medical device industry employees
- Consultants
- Auditors
- Regulatory personnel
- Purchasing department personnel
- Employees of companies that provide contracted services to Medical Device Manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, testing house
- Clinical research professionals conducting trials of medical devices on devices in the EU or planned devices to be placed into the EU market
- Contract Research Organizations
- Individuals seeking work opportunities in the medical device industry
- Employees of a contract manufacturing company
- Any service provider for the medical device industry
- Anyone who is part of the supply chain
- Managers
- CEOs
- CFOs
Preface: - Welcome and Introduction
- Course Objectives
- Course Content and Structure
- Course Materials and Format
EU legal framework: - Entry into Force, Date of Application, and Transitional Provisions
- CE marking
- EU Market Product Release Process
- Legal framework on Release of Regulation 2017/745
- UKCA mark
- Structure of the Regulation
- European Commission Objectives
- Top Level Review of the Regulation
- Responsibilities
Scope: - Intended Purpose
- Definition of Medical Device and Accessories
QMS: - Quality Management System Requirements
- ISO 13485
- ISO 14971
- Language Requirements
- Commons Specifications and Standards
- MDCG Guidance Documents
Other Requirements: - Strategy for Regulatory Compliance
- Competence of Persons and Authors
- Liability Insurance
- Certificate of Free Sale
Risk Class: - Device Class
- Device Risk Classification
Conformity Assessment: - Pillars of Technical Documentation
- Conformity Assessment
- Routes to Conformity
- Quality System Based Assessment Annexes
- Product Based Assessment Annexes
- Assessment Route Considerations
GSPRs: - General Safety and Performance Requirements
- General Requirements
- Types of Information Supplied with the Device
- Clinical Evaluation
- Clinical Investigations
- SSCP
-
Technical Documentation: - Content and General Requirements
Apply: - MDR Designated NBs and MDR Codes
- NB Conformity Assessment
- Additional Procedures
- Certificate Scope
- SRN, UDI, EUDAMED
- DoC and CE Marking
PMS+: - Post Market Surveillance and Updates
- Post Market Surveillance
- PSUR
- Post Market Reports
- Plans needed under the MDR
- Vigilance
- Actions of Competent Authorities after Report
- FSCA and FSN
- Grace Period and Significant Changes
- Additional Information