Blog

Timely, insightful, and relevant thoughts, opinions, and discussion on FDA software validation, 62304 compliance, medical device software standards, updates impacting medical device and HealthIT software development, and sundry subjects from our Partners and staff.

For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...
Read More
Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...
Read More
Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
Read More
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
Read More
Health Canada released the full guidance document, Pre-market Requirements for Medical Device Cybersecurity. It can be viewed at:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.htm It includes requirements such as: “Risk management is required for all medical devices throughout their life-cycle. Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are...
Read More
This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. As more "software as a medical device" (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with...
Read More
Another useful reference for establishing a safety culture in your software organization. “The purpose of this Handbook is to define the NASA Safety Culture Program and to provide guidance in the development and implementation—sustainment, growth, and practice—of Safety Culture at the Center level. It defines the NASA Safety Culture Model, describes the Safety Culture Survey...
Read More
This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own...
Read More
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
Read More
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
Read More

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.