Day

November 14, 2010
The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
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This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”
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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

Email office@softwarecpr.com
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