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
Our courses are most often conducted by the experts involved in the development of the standard. The course also focus on practical issues what manufacturers and suppliers need or should do based on our hands-on experience from the medical device industry.
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.
- 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
Course material will be in English.
Verbal presentation and discussions can be provided in Swedish or English.
After successfully completed course including a proficiency test participant will receive a certificate
Quality managers, internal auditors and process owners at medtech manufacturing companies.
Need of prior Knowledge/Experience
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.
After the course you will have a solid foundation for, and understanding of, the implications for the medtech industry.
QAdvis consultant/s based on the specialist competence required for each course
Contact Please contact us for a discussion, content specification or proposal at firstname.lastname@example.org