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.
FDA 201: Foundations of FDA Regulatory Compliance; Integrating ISO 13485 for the Medical Device Industry
Course Last update in March of 2024
This course is a 4-Day Live Online Course designed to equip students with the advanced practical skills expected of a Subject Matter Expert.
Upon successful completion of the course, students will receive a prestigious certification, and will be awarded 3 Continuing Education Units (CEUs), acknowledging the professional development achieved through this rigorous program.
Current Course Schedule Options:
* June 4 - 7 2024 from 9:00am to 4:00pm EST
* July 8 - 11 2024 from 9:00am to 4:00pm EST
Don't miss this opportunity to enhance your knowledge and advance your career.
Register NOW
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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
First and foremost, I want to express my sincere gratitude for considering my course.
With almost two decades in the medical device industry, mastering every aspect from conception to market release, I've honed expertise in design, development, and quality management systems. Transitioning to auditing roles within notified bodies, I gained unique insights into regulatory frameworks, which I now impart in my course, Foundations of FDA Regulatory Compliance: Integrating ISO 13485 for the Medical Device Industry.
As someone who has successfully navigated various roles in engineering, auditing, and consulting within the medical device sector, I bring a wealth of practical insights to the classroom. My mission is to empower both new entrants and seasoned professionals with the knowledge and skills needed to excel in regulatory compliance and product development.
When it comes to competence, course delivery and trainer experience matters.
The FDA 201 Course stands out as a premier online training program, uniquely developed by an expert with multifaceted experience in the medical device industry.
As a seasoned professional with a background as a Biomedical Engineer, Lead Auditor for Notified Bodies, Consultant, and former industry member, I've curated this course to offer unparalleled insights into FDA regulatory compliance. Drawing from years of hands-on experience across various pivotal roles, I ensure that participants gain practical knowledge and in-depth understanding of FDA regulations, seamlessly integrated with ISO 13485 standards. Join me on this journey to master regulatory compliance and elevate your expertise in the medical device industry.
Hi, I’m Isabel Osorio
First and foremost, I want to express my sincere gratitude for considering my course.
With almost two decades in the medical device industry, mastering every aspect from conception to market release, I've honed expertise in design, development, and quality management systems. Transitioning to auditing roles within notified bodies, I gained unique insights into regulatory frameworks, which I now impart in my course, Foundations of FDA Regulatory Compliance: Integrating ISO 13485 for the Medical Device Industry.
As someone who has successfully navigated various roles in engineering, auditing, and consulting within the medical device sector, I bring a wealth of practical insights to the classroom. My mission is to empower both new entrants and seasoned professionals with the knowledge and skills needed to excel in regulatory compliance and product development.
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, participants will gain a thorough understanding of FDA regulatory compliance and its integration with ISO 13485 in the medical device industry. With a focus on regulatory frameworks, quality management systems, and key aspects of the design and development process, you will develop the expertise needed to ensure regulatory adherence at every stage of product development. From navigating the FDA regulatory landscape to implementing risk management strategies and addressing ethical considerations, you will emerge equipped to confidently navigate the regulatory complexities of the medical device industry.
Practical Tools
In this course, we don't just skim through regulations and standards; we break them down into easily understandable segments. Moreover, you'll receive practical tools that you can implement immediately in your work.
Real-world Perspective
Led by Isabel Osorio, this course offers invaluable real-world insights garnered from her extensive experience in biomedical engineering, auditing, and consultancy within the medical device industry. Gain practical knowledge and industry best practices that transcend theoretical concepts, equipping you to confidently navigate regulatory challenges.
Reimbursement Opportunities
Explore potential reimbursement opportunities with your employer. You might be eligible to take this course at no personal cost. Don't miss out on this chance to enhance your expertise and advance your career.
Who Is This Course For?
Engineers
Gain a comprehensive understanding of FDA regulatory compliance and ISO 13485 integration, ensuring product compliance from the initial design phase.
Members of Industry
Ideal for those involved in selling or planning to offer medical device products or related services in the U.S. This course provides essential insights into FDA regulatory requirements and quality management systems.
New Product Development Professionals:
Ideal for business owners, doctors, scientists, or any individual involved in developing new medical device ideas. Gain the necessary knowledge and skills to navigate FDA regulatory compliance and integrate ISO 13485 standards into the product development process effectively.
Quality Assurance (QA) & Regulatory Affairs (RA) Personnel
Tailored for professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles, providing in-depth knowledge and practical skills to navigate FDA regulatory requirements effectively.
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, participants will gain a thorough understanding of FDA regulatory compliance and its integration with ISO 13485 in the medical device industry. With a focus on regulatory frameworks, quality management systems, and key aspects of the design and development process, you will develop the expertise needed to ensure regulatory adherence at every stage of product development. From navigating the FDA regulatory landscape to implementing risk management strategies and addressing ethical considerations, you will emerge equipped to confidently navigate the regulatory complexities of the medical device industry.
Practical Tools
In this course, we don't just skim through regulations and standards; we break them down into easily understandable segments. Moreover, you'll receive practical tools that you can implement immediately in your work.
Real-world Perspective
Led by Isabel Osorio, this course offers invaluable real-world insights garnered from her extensive experience in biomedical engineering, auditing, and consultancy within the medical device industry. Gain practical knowledge and industry best practices that transcend theoretical concepts, equipping you to confidently navigate regulatory challenges.
Reimbursement Opportunities
Explore potential reimbursement opportunities with your employer. You might be eligible to take this course at no personal cost. Don't miss out on this chance to enhance your expertise and advance your career.
Don't waste money on courses that just repeat regulations. Our FDA 201 course offers practical insights and actionable strategies to navigate FDA compliance effectively. Invest in knowledge that delivers real results for your career and organization.
Maybe you have colleagues who have taken a course on this topic and were still unclear on it all.
That will not happen with this course.
What We Will Cover:
FDA Regulatory Framework
Medical Device Quality Management Systems (QMS) Requirements
Design and Development Process including integration of Risk Management
Process Development, Verification, and Validation
Design Transfer, and Post-Market Surveillance
Business Strategies,
Ethical Considerations, and Compliance Adherence
Medical Device Companies trust MDR Consultants for best-in-class staff training
Why do they 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
The FDA 201 Course brings this complicated topic to life with real life examples from Isabel Osorio's extensive experience in the biomedical engineering industry, auditing for Notified Bodies, and consultancy within the medical device sector.
Stay ahead of the curve and certify your competence in FDA regulatory compliance and ISO 13485 integration for the medical device industry with FDA 201.