April 8, 2020
Company: Ra Medical Systems, Inc. Date of Enforcement Report: 4/8/2020 Class II PRODUCT Pharos Excimer Laser, Model: EX-308 – Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region...
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Company: Haemonetics Corporation Date of Enforcement Report: 4/8/2020 Class II PRODUCT TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies Recall Number: Z-1617-2020 REASON Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to...
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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

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