Manufacturer remote access to medical device

For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive and appropriate for other types of devices.

This standard is entitled:
13-28 Remote Access to Clinical Laboratory Diagnostic Devices via the Internet CLSI AUTO9-A
CLSI is the CLinical and Laboratory Standards Institute.

The FDA consensus standards can be found here: FDA consensus standards.

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

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