Day

March 31, 1998
Bioresearch 3/31/98 TMJ diagnosois software Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that...
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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
for more info!

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