Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• European Authorized Representation
1-day course 22 October in Stockholm and 24 October in Malmö 2019.
EU Medical Device Regulation (MDR)
MDD to MDR – Key changes and implementation
Prepare your organization for an efficient transition
The Medical Device Directive will be replaced by the Medical Device Regulation (MDR 2017/745) in spring 2020. The transition period for the regulation on the European market runs from May 2017 to May 2020.
The new regulation will have a great impact on all medical device actors throughout the lifecycle of their products, with stricter requirements on both devices and manufacturers’ Quality Management Systems.
QAdvis offers a 1-day course 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.
- 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
- Quality and regulatory professionals working with medical devices
- Management of device companies
- Other medical device company employees who need to learn about the impact of MDR
The course has been developed for participants who have a basic knowledge of MDD and ISO 13485.
Course material will be in English, verbal presentation and discussions in Swedish.
Emma Axelsson and Anneli Wiedenkeller, Senior Medical Devices Quality and Regulatory Consultants at QAdvis.
Participants’ evaluations of this MDD to MDR course:
- Energetic and inspiring lecturers
- Presenters professionality very good
- Good overview & small group = easy to ask questions
- Very good summary of the new regulatory requirements
- Useful implementation suggestions at the end of the presentation
Date and location
22 October, Stockholm – Kista Entré Konferens, Knarrarnäsgatan 7, 164 40 Kista
24 October, Malmö – Radisson Blu, Östergatan 10, 211 25 Malmö
Price and registration
Course fee is 7,350 SEK, excl. local VAT (moms). Price includes printed course material, printed MDR 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.
Register by sending an e-mail to firstname.lastname@example.org Please specify:
- E-mail adress
- 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.
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.
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.