Introducing Medical Device Regulation Training
With this interactive training program, you will:
- Receive a recognised certificate from TÜV SÜD, demonstrating your understanding of the European Union's Medical Device Regulation (EU) 2017/745.
- Gain essential knowledge of the key changes introduced by the MDR, including new classification rules, stricter clinical evidence requirements, and enhanced post-market surveillance obligations.
- Develop a thorough understanding of your responsibilities and obligations as a manufacturer, EU representative, importer, or distributor of medical devices across Classes I to III.
- Learn about the new legal requirements for efficient and safe manufacture of medical products in accordance with the MDR.
- Acquire practical insights into the MDR's impact on product lifecycle management, from design and development to post-market surveillance and clinical follow-up.
- Network with professionals from various sectors of the medical device industry, sharing experiences and building relationships with peers facing similar regulatory challenges.
- Enhance your professional qualifications and broaden your career prospects in the fields of regulatory affairs, quality management, and medical device development.
- Prepare yourself to support your organisation in achieving and maintaining compliance with the MDR, ensuring the safety and performance of medical devices in the European market
What will you learn?
At the end of the course, you will:
- Understand the requirements of MDR
- Learn about the European guidance documents (MEDDEVs), the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluation and Post-Market Clinical Follow-up (PMCF).
Course outline
In this program, you will learn the following:
- Introduction to MDR
- Classification of medical devices
- Conformity assessment procedure
- Technical documentation requirement
- General Safety and Performance Requirements
- Clinical data & clinical evaluation requirements
- Post-Market Surveillance, vigilance and market surveillance requirements
Who should attend?
The course is specially designed for:
- Quality & Risk Management, R&D, Manufacturing, etc.
- Anyone who is working in the Medical Device sector that market products to the EU
Learning & Career Prospects
The career prospects for the Introducing Medical Device Regulation (MDR) Training Programme are excellent. As the medical device industry faces increasingly stringent regulatory requirements, there is a growing demand for professionals with expertise in MDR.
Career prospects include:
- Regulatory Affairs Specialist
- Quality Assurance Manager
- Compliance Officer
- Clinical Affairs Specialist
- Medical Device Consultant
- Regulatory Compliance Auditor
Trainer Profile
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
Examination & Certification
Upon completing the course, you will receive a certificate from TÜV SÜD.
FAQ
1. Can I also attend e-learning courses on top of attending the Introducing Medical Device Regulation course?
Yes, you can register for any e-learning course at TÜV SÜD.
2. How do I enroll for the Introducing Medical Device Regulation course?
To enroll, please click on "Buy now" and check out your cart.
3. What is the Introducing Medical Device Regulation course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
4. Can I get a refund if I cancel my enrolment?
- If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
- If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.
5. Are there any tests in the middle of the course?
There are no in-between assessments, but case studies will be included in the Introducing Medical Device Regulation course.