Overview of SEI CMM

“Capability Maturity Mode Implementation and Risks” byTracey Briscoe of Quality Systems and Software (maker of the DOORS requirements management tool).This white paper provides a concise overview of the CMM and some common issues regarding its value, costs, and implementation approach. Quality Systems and Software has a variety of white papers and courses offered on its website (www.qssinc.com) including 1 and 2 day courses on improving Requirements Analysis. Their DOORS product includes templates to assist in meeting FDA’s Medical Device Quality System Regulation Design Control Requirements and interfaces with Mercury Interactive’s Test Director to link requirements to testing. The tool is quite powerful and flexible and can be used for software requirements management or overall product development design input and requirements analysis and traceability. …Provided with the permission of QSS.

QSSCMM Overview

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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