NSF International – Training Courses for Medical Device Professionals

NSF International has announced a range of training courses for professionals working in the medical device industry.

If you are interested in registering for any of the courses, please make an enquiry using the form on this page or visit www.nsf.org/training-education.

CQI/ IRCA Certified QMS Lead Auditor Training

This five-day course provides the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based on case studies that simulate both supplier and third-party audits utilising the Medical Device Single Audit Program (MDSAP) audit requirements.

You will participate in simulated auditing exercises, including planning, preparation and evaluation of audit evidence, all while practising the application of ISO 13845:2016 and the MDSAP requirements.

Available dates:

  • 11 June to 15 June in Galway, Ireland
  • 9 July to13 July in Reston, Virginia
  • 10 September to 14 September in Hamburg, Germany

510(k) Premarket Notification Workshop

This two-day workshop is a one-stop-shop to learn about the clearance process and compliant marketing of medical devices through the 510(k) programme.

This workshop provides a comprehensive overview of one of the UD Food and Drug Administration’s (FDA) primary premarket pathways.

Available dates:

  • 22 October to 23 October in Hamburg, Germany
  • 24 October to 25 October in Zaventem, Belgium

Medical Device Regulatory Country-Specific eLearning courses

NSF International is one of the first organisations to launch this eLearning training series, which provides in-depth knowledge of the regulatory requirements of Australia, Brazil, Canada, Japan and the US. Each session is structured in a consistent format to enhance the user experience.

Each course includes knowledge checks and final exams to test understanding and provide evidence of competency as required by ISO 13485:2016.

MDSAP Overview Training

This is a web-based course offering your organisation the flexibility and efficiency of a virtual classroom to prepare for MDSAP.  Presented by Kim Trautman, a former US FDA official and a key member of the original MDSAP development team, this course teaches the basics of the new non-conformance grading system and what grades trigger regulatory follow-up.

You’ll learn about the MDSAP audit model, audit time calculations, the information to be included in the audit report, and the MDSAP timeline.

This course includes a final exam and a Certificate of Successful Completion, providing evidence of competency as required by ISO 13485:2016.

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