Day

September 22, 2020
This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment.  This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version...
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62304 Public Training Course DATES:  December 22-24, 2020 (Registration is open through December 9, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount:  3 or more register and get $200/person off (up to course size limit) This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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