Tag

compliance
17
Nov

Compliance and Agile – Another Common Hurdle

November 17, 2020
Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...
Read More
22
Mar

White Paper Compliant Use-Microsoft Visual Studio

March 22, 2014
The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010
Read More
09
Nov

$Compliance Training templates for Software$

November 9, 2009,
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of...
Read More

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.