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

2-day course, 10-11 March 2020.

EN ISO 13485:2016 – Medtech quality management systems

Are you planning to put a medical device on the market? Are you a medical device manufacturing company, or a supplier of medtech services? If your customers have certain requirements on your quality management system, this course is for you! Here is your chance to learn everything about the new 2016 version!

The harmonised EN ISO 13485:2016 standard is used for compliance with the regulations and constitutional requirements needed to be able for supplying medtech products and associated services in the EU. By employing a quality management system according to the standard, you fulfil the applicable sections of Läkemedelverket’s rule LVFS 2003:11 (which corresponds to the medical device directive, MDD).

Welcome to our two-day course in EN ISO 13485:2016! In this course, we will explain the requirements of the standard, and describe its interpretation and application. The course provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system. Having a quality management system according to ISO 13485:2016 is, in many cases, a prerequisite to getting a CE-mark.

From the programme
· ISO 13485:2016 – background, purpose, scope and future
· Changes to the auditing process
· Relation to ISO 9001 / LVFS / MDD / ISO 14971
· Quality management principles
· A walkthrough of the requirements in ISO 13485:2016
· Quality management systems
· The responsibility of management
· Resource management
· Product design
· Measurements, analysis and improvements
· The road to certification
· Maintaining a management system
· Practical exercises

The goal of the course
After the course you will have a solid foundation for, and understanding of, the implications for the medtech industry.

Who is this course for?
Quality managers, internal auditors and process owners at medtech manufacturing companies.

Required prior knowledge
A basic knowledge of ISO 9001 is recommended. This course makes a good combination with our course Risk management for the MedTech industry – according to ISO 14971.

Course Leader
Camilla Drott, Quality and Regulatory Consultant at QAdvis
More about Camilla>

Date and Location:
10-11 March 2020, IDEON, Scheelevägen 17, SE-223 70 Lund

Day 1: 09.30-16.30 (Registration and coffee from kl. 09.15)
Day 2: 09.00-16.00

Price and registration
Course fee 11 900 SEK, excl. local VAT (moms). Price includes printed course material, 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 e-mail to academy@qadvis.com.

Please specify:
• Name
• E-mail
• Title/position
• Company
• Invoice address
• Any food related allergies

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.

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.