Cybersecurity Article

Sherman Eagles of SoftwareCPR® recently coauthored an article published by AAMI in the Jan/Feb 2016 BIT Journal entitled “Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality.”  You can read the article at this link: 2016 Jan-Feb BIT Cybersecurity

Sherman is well known as an expert in medical device standards and has been involved in many standards activities with IEC, ISO, and AAMI. Sherman also leads our Standards Navigator subscription which provides monthly updates on standards work.  Click here to subscribe!

Sherman and otherSoftwareCPR® experts can assist you with training and consulting related to Cybersecurity and compliance with regard to FDA guidance and current enforcement.  Contact us today to discuss how we could help your company with cybersecurity compliance and planning.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

for more info!

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