Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• Training
• European Authorized Representation

QAdvis Online course, 26th and 28th May, 2020.

MDD to MDR – Key changes and implementation

One day course divided in to two half-day sessions

Prepare your organization for an efficient transition. The new regulation will have a great impact on all medical device actors, throughout the lifecycle of devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems.

QAdvis offers an online course, in two sessions, on the new regulation, to give you a basic understanding of the new requirements and help you get started on the transition project.

This course provides an insight into some of the most important aspects of the new requirements. It will help you begin implementing the new regulation and make your transition as efficient as possible.

Topics

  • Key changes when transferring from MDD to MDR
  • Common specifications
  • Classification rules and conformity routes
  • Overview of requirements on technical documentation
  • General safety and performance requirements (GSPR)
  • Post-market surveillance
  • UDI and product labelling
  • Clinical evaluation and requirements on clinical data
  • Impact on quality management systems
  • Implementation timeline
  • Implementation plan and guidance on how to conduct a gap assessment

Target group
This course is intended for quality and regulatory professionals working with medical devices, medical device company management and employees who need to learn more about the impact of the MDR.

Recommended prior knowledge
Participants should have a basic knowledge of the Medical Device Directive, MDD, and of ISO 13485.

Course Leader
Emma Axelsson, Senior Quality and Regulatory Consultant

Presentation
Course material will be in English, the verbal presentation and discussions will be held in Swedish.

Location: 2 half-day sessions online, TBA*
Date: 26th and 28th May, 2020
Time: 08:30 AM – 12:00 AM CEST

*You will get detailed information for how to attend, in the confirmation e-mail

Price
Course fee is 7,650 SEK, excl. local VAT (moms). For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Price includes printed course material and printed MDR book. Both will be sent to you in advance. Training certificate will be sent to you after attending both half days.

Registration
Register by sending an e-mail to academy@qadvis.com and specify:

  • Name
  • E-mail adress
  • Title/position
  • Company
  • Invoice address:
  • Course material sends to

To be able to send course material in advance we need your information at the latest on 18th May. Registration will be valid upon returned confirmation by QAdvis.

Don’t hesitate to contact us at academy@qadvis.com for any question about this course.

Terms
Cancellations must always be communicated to academy@qadvis.com and confirmed by us. Cancellations made more than 3 weeks before the starting date are free of charge. Cancellations made 3-2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.

QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.

Force majeure
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.