Medical Device Training

Spiral Medical Development provides training for its areas of expertise in medical device development. Quality Management Systems (QMS's) require proof of training and expertise to comply with various national and international standards/regulations. We issue a certificate as proof of training, and you can use that for your training file to remain compliant with documentation of team member expertise.

Trainings are collaborative seminars with instruction and hands-on learning activities that come in two forms, chosen by the client:

In person (onsite) - One to three days in person (8 hours/day with breaks)
Online - Two to five days via Zoom (4 hours/day with breaks)

The following courses are offered in these onsite or online formats:

ISO13485 Design Controls for Medical Devices
ISO13485 Medical Device Quality Systems
ISO14971 Medical Device Risk Management
European Medical Device Regulation Basics and Introduction
Clinical Evaluation for Medical Devices
Worldwide Post-market Surveillance of Medical Devices