Now available in a travel-free LiveOnline classroom!
The revised Medical Device Regulation (2017/745) entered into Force in 2017 and has date of application May 26, 2021. This course provides a knowledge of the requirements of the regulations including the requirements for Technical Documentation and Quality system requirements.
This 3-day course is designed to help you:
- Analyze the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation)
- Understand the structure of the MDR
- Understand essential requirements of the MDR.
- Gain knowledge about certification processes at Notified Body (NB).
Live Instructor-led Training; Virtual or On-site Classrooms To meet today’s high demand, constrained budgets, travel restrictions and personal safety, DNV GL now offers this training as both a LiveOnline (virtual) class. No travel needed. Take the course while at work or in your home office! You may also have the course presented on-site at your preferred location, pending travel advisories and restrictions.
Course Agenda
Day 1
- Introduction of DNV
- MDR overview and status of transition
- MDD vs. MDR key changes
- Scope of MDR & key definitions
- General responsibility of manufacturers
- Economic operator / UDI
Day 2
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (MDR) vs ERC (MDD)
Day 3
- MDR Post Market Surveillance and PMCF
- SSCP & PSUR
- Vigilance
- MDR Medical Device Quality Management System
Who Should Attend?
This course is highly recommended for
- Managers and personnel responsible for the CE certification of medical devices
- Regulatory Affairs officers responsible for certification for medical devices
- Quality Assurance personnel responsible for device and system compliance
- CE certification consultant of medical devices.
Recommended follow-up courses:
ISO 13485:2016 Medical Device QMS Foundation, ISO 14971 Medical Devices Risk Management
Class Hours:
In Class: 8:30 a.m. - 5:00 p.m.
LiveOnline: 9:00 a.m. - 4:30 p.m. CST.
- LiveOnline classes are delivered in 90 minute sessions, each followed by 30 minute breaks
- Up to four (4) sessions per day
Cancellation, Transfer, Substitution, and "No-Show" Policy:
In-class
More than 30 days to the start date of the course, a registrant may:- Request to cancel a registration and receive a full refund, or
- Request to transfer to a different class at no charge.
- Request to cancel a registration and receive a 50% refund, or
- Request a transfer to a different class and remit a $100 fee to process a transfer.
Less than 15 days prior to the start date of the course (including no-shows on the day of the course), no refunds or transfers are provided.
LiveOnline
10 days or more prior to the start date of the course, a registrant may:
- Request to cancel a registration and receive a full refund, or
- Request to transfer to a different class at no charge.
- Request to cancel a registration and receive 50% refund, or
- Request to transfer to a different class and remit a $100 fee to process a transfer.
- No withdrawals or transfers
- Fee is non-refundable.
Substitutions (another person replacing a particular registrant in a course) are permitted at any time without additional charge.
Should DNV cancel a schedule course, our liability to course registrants is limited to the amount of the course fee. The registrant would then have the option of a full refund or transfer to an alternative available course (transfer fee is waived in this situation). We recommend that registrants wait until the course date is less than 30 days out before making travel arrangements.
**To register for a course, you may click the "location" link below to pay by credit card or you can contact us to pay by invoice.
PLEASE NOTE:
- There will be a 10% administration processing fee for generating invoices.
- Discount codes are not applicable on invoiced orders.
