Course description
ISO 13485:2016 – International Medical Device QMS Standard
This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device quality management system (QMS) regulations around the globe. This course covers the goals of the standard and in-depth instruction regarding Clause 4-QMS; Clause 5-Management Responsibility; Clause 6-Resource Management; Clause 7-Product Realization; and Clause 8-Measurement Analysis and Improvement.
Upcoming start dates
Outcome / Qualification etc.
Certificate
By completing/passing this course, you will attain the certificate Medical Device Certificate
Training Course Content
By the end of this course you should be able to:
- Define the primary purpose of ISO 13485:2016
- Identify the general and documentation requirements of a QMS as outlined in Clause 4
- Recognize the responsibilities of management within a QMS as outlined in Clause 5
- Identify the resources needed to implement and maintain an effective QMS; and meet regulatory and customer requirements as outlined in Clause 6
- Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
- Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Expenses
Course price: $399.99
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.