Welcome, in this course we will give you a complete run-through of the EN ISO 13485:2016; Medical devices — Quality management systems — Requirements for regulatory purposes.
Differences with the previous version ISO 13485:2003/2012 are specifically highlighted.
The course will go through all clauses and requirements and discuss interpretation and practical implications. It provides a basic understanding of the requirements and how to establish and maintain a well working quality management system.
A quality management system according to ISO 13485:2016 is in many cases a practical prerequisite for CE-marking and other national regulatory approvals of medical devices and in-vitro diagnostic medical devices.This latest revised standard is also targeting other operators such as suppliers, distributors, importers within the medical device supply chain.
• ISO 13485 – History, purpose, scope and future
• Quality management system – The big picture, CE-marking
• Relation with ISO 9001 / LVFS / MDD / MDR
• Requirements and interpretation of EN ISO 13485:2016
• Quality management systems
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement
• Practical exercises
Course material is in English. Verbal presentation and discussions in Swedish.
Nils-Åke Lindberg, who has 30 years of experience in the medical device industry with numerous audits and actively participating in EU COM medical device working groups and standardization committees; ISO/TC210/WG1 and SIS/TK355 who has been part of development of ISO 13485:2016.
Date and location
21 – 22 May, 2019 at
Radisson Blu Hotel, Östergatan 10, 211 25 Malmö
Day 1: 09.30-16.30, registration and coffee from 09.00
Day 2: 09:00-16:00
Personnel within QA, development, production, management, internal auditors, process owners, regulatory, etc at companies within the medical device supply chain.
Basic knowledge of quality systems, ISO 9001, 13485, GMP, etc is preferred.
Course fee 11900 SEK, excl. local VAT (moms). Price includes printed course material, training certificate, lunches and coffees. EN ISO 13485:2016 standard in not included but can be borrowed during the course.
Invoice will be sent at time of course registration.
Group registrations, 2nd and 3rd person from the same company a 10% discount is applied. For 4th and additional persons 25% discount.
Register by e-mail to Academy@qadvis.com
• Invoice address
• Any food related allergies
• Registration will be valid upon returned confirmation by QAdvis.
If you need hotel accommodation you can use QAdvis discount, between 10-20% on selected business hotels within walking distance to the training venue. Contact us for information about hotels and discount if needed.
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.