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Posts tagged "ISO 14971"

Why there is a change in the approach regarding labeling as RISK mitigation

July 24th, 2013 Posted by 510(k), CE Marking, FDA, IEC60601, ISO 14971, Recall, RISK Assessment, Risk Management 0 thoughts on “Why there is a change in the approach regarding labeling as RISK mitigation”

A recent recall on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: class 1 recall – mislabeled packaging – See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/bryan-medical-tracoe-mini-30mm-tracheostomy-tube-class-1-recall/ has proven some of the justification regarding the change in approch when putting labeling as part of the RISK mitigation. In the above case in the RISK assessment we should expect to see that not just labeling should be used to differentiate between the different devices but also packaging and coloring could be a good way to use on the device. Such mistake in labeling could affect patient safety since an oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. When we come to RISK assessment and decide to use labels as mitigation we may want to consider mistakes in packaging and address such cases as well or even perform change by design to avoid use of the device on the wrong application.

Orcanos 6th Medical Event – Regulation & Standards by Sherman Eagles

May 8th, 2013 Posted by Presentation 0 thoughts on “Orcanos 6th Medical Event – Regulation & Standards by Sherman Eagles”

Presented by: Sherman Eagles

 

Presentation Content: 

  • Recent regulatory activities
  • Recent standards activities
  • Emerging issues
  • Medical device security
  • Medical device interoperability
  • Mobile medical apps

 

The Presentation: Regulation and Standards by Sherman Eagles

ISO 14971 For Medical Device Risk Management

February 23rd, 2011 Posted by ISO 14971, Standards and Regulations 0 thoughts on “ISO 14971 For Medical Device Risk Management”

ISO 14971 represents the requirements for a medical device risk management system.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485.

ISO 9000 Quality Standards

  • ISO 9001:  Design and Manufacturing
  • ISO 9002:   Manufacturing Only
  • ISO 9003:  Inspection and Testing Only

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