Spiral Medical Development

Spiral Medical Development provides training 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.

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

(Click links to find out more.)

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• Clinical Evaluation for Medical Devices

• European Medical Device Regulation Basics and Introduction

• ISO13485 Design Controls for Medical Devices

• ISO14971 Medical Device Risk Management

• ISO13485 Medical Device Quality Systems

• Worldwide Post-market Surveillance of Medical Devices

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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)​​

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