Day

May 9, 2019
Zeller Power Products, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570909 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Zeller Power Products, LLC., located at 6585 Arville Street, Suite A, Las Vegas, NV, from November 6 – 9, 2018. During the inspection, an FDA investigator...
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Rechargeable Power Energy North America, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570911 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Rechargeable Power Energy North America, LLC located in Las Vegas, Nevada, from November 5 – 9, 2018. During the inspection, an FDA investigator determined...
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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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