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Medical Device Classification

 Dan O'Leary CBA CQA CQE CRE SSBB CIR
  9th-Jan-2017
Description: Factors That May Affect Risk: -Device design should incorporate the principles of inherent safety. Manufacturing processes must be well planned and under control. The validated process ensures conforming output and reduces the compromise to safety. This is the objective intent of the manufacturer on how the device will be used. The intended use will define the “scope” of use, and, in particular, places where the device is not intended for use. Define the anticipated user. Identify the expected user’s skill level-Home use devices should be simple to operate, Complex devices may require higher levels of training.
Views: 980
Domain: Medical
Category: Implants
Contributing Organization: Ombu Enterprises, LLC
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Contents:
Medical Device Classification
Dan O’Leary CBA, CQA, CQE, CRE, SSBB, CIRM
President
Ombu Enterprises, LLC
Dan@OmbuEnterprises.com
www.OmbuEnterprises.com
603-209-0600

Medical Device Classification

Ombu Enterprises, LLC

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Speaker Biography


Dan O’Leary
– Dan O’Leary is President of Ombu Enterprises, LLC, an education,
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