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

EU In Vitro Diagnostic Regulation Course (IVDR)

IVDD to IVDR – Key changes and implementation
Prepare your organization for the transition

The transition period for regulation 2017/746 for IVD devices on the European market is May 2017 to May 2022. The new regulation will have a great impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ QMS’s, throughout the product lifecycle.

QAdvis offers a 1-day course on the new regulation, to give you a basic understanding of the new requirements and help give you a head start in the transition project

Join this course to start developing an understanding of the new requirements and learn how to begin your implementation, and make your transition as efficient as possible.

Topics

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

Target group

  • Quality and regulatory professionals working with In Vitro Diagnostics
  • Management of IVD companies
  • Other IVD company/laboratory employees who need to learn about the impact of IVDR

The course has been developed for participants who have a basic knowledge of IVDD and ISO 13485.

Course material will be in English, verbal presentations and discussions in Swedish.

Course leader
Two QAdvis specialists.

Date and location
This course is planned for 30 September 2019, Stockholm and 2 October 2019, Malmö.

Price and registration
Course fee is 7,350 SEK, excl. local VAT (moms). Price includes printed course material, printed IVDR book, a short test, training certificate, lunch and coffees. An invoice will be sent 2 weeks before course date. 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.

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

  • Name
  • E-mail adress
  • Title/position
  • Company
  • Invoice address
  • Any food-related allergies
  • If you want to attend the course in Malmö or in Stockholm/Kista

The registration will be valid upon returned confirmation by QAdvis.

Terms
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 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.