Introduction to ISO 13485:2016 Medical Devices

Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with with ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation. The relationship with ISO 14971, Application of Risk Management to Medical Devices is also explored during the course.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the standard
"Our international reach is unrivalled with operations in 147 countries"

What will I learn?

On completion of this training, participants will be able to:

  • Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Understand the relationship between ISO 13485:2016 and European Medical Device Directives
  • Use ISO 13485:2016 as the basis of regulatory requirements worldwide.

How will I benefit?

This course will help you:

  • Take the first steps towards ISO 13485:2016 certification
  • Understand how you can better meet regulatory requirements leading to increased patient safety
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices
  • Motivate employees through CPD.

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >

Course Guide

Download Course Guide


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.


Save on your learning journey with the BSI Training Academy*

With BSI training online, you can unlock discounts when booking your learning pathway, helping you shape your next few weeks, months or years of development – whilst saving in the process.

Make the most of your training budget by booking your next 2 or more courses with BSI before 27 November 2020 and you’ll save:

  • 15% off your next course

  • 20% off your second course

  • 25% off your third course

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com.

*Terms and Conditions: Applies to all public BSI UK training courses, booked before 27 November 2020 and delivered within 12 months, via Connected Learning Live (online training) only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Discounts applicable when booking 2 or more courses. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. This offer does not apply to BIM qualifications, where existing course packages are available. Offer is valid for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.