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clinical
Why is a SR or NSR Designation important? The FDA guidance document, “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies,” sheds some light on the Investigational Device Exemptions (IDE) regulations of 21 CFR 812. The IDE regulations describe significant risk (SR), nonsignificant risk (NSR), and exempt...
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Why are clinical studies necessary? Medical device clinical studies provide evidence for a PMA submission. Under 21 CFR 860.7, the FDA relies only on “valid scientific evidence” to determine whether there is reasonable assurance that a device is safe and effective. Valid scientific evidence can originate from a variety of sources, including well-controlled studies. Even...
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On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses...
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The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_Investigations
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes select FDA documents as well as SoftwareCPR training aides and checklists that SoftwareCPR uses in its training courses on Validation of Clinical Trials Computer Systems. The PDF is over 2 MB so be patient downloading...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Our SoftwareCPR audit checklist for assessing conformance with the FDA Guidance for "Computerized Systems Used in Clinical Trials" can be viewed and downloaded at this link:  ClinicalTrialsSWFullChecklist. This checklist has been updated by Mary Decareau of SoftwareCPR to reflect...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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