FDA/IMDRF Draft–Standalone SWClinical Evaluation

OBSOLETE – Final Issued December 8, 2017FDA issued a draft guidance developed as part of the Internation Medical Device Regulators Forum entitled “Software as a Medical Device (SaMD): Clinical Evaluation”. This document focuses on how to demonstrate clinical validatity of software as a medical device. Other guidances from FDA and IMDRF address other software aspects such as software validation, premarket submissions, and risk classification among others.

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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