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>

Dates
5–6 November 2019