Tag

14971
This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. ISO 14971 was updated and released in 2019.  We previously discussed the internal debate regarding ISO 14917 in this post ISO 14971 versus the EU Commission. There are several items to consider with the new update: Section 10.1 - “The manufacturer...
Read More
ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...
Read More
What concerns FDA when conducting a benefit-risk assessment of medical devices?  The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...
Read More
In SoftwareCPR’s opinion, a somewhat unique, very well conceived, and well designed tool for the specialized craft of risk analysis as well as safety assurance cases.  The tool is very configurable, allowing customized structures for your own methods.  The ability to view data from an FMEA, FTA, or table view saves valuable time during creation...
Read More
This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the formal objection to the harmonization of ISO 14971 from the European Commission.   EN Deharmonization of Cen-Standards 2010-11
Read More
This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the response from ISO TC 210 to the EC objections to ISO 14971.  ISO TC210 Comments on deharmonization of EN14971
Read More
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed.  This example is modeled on the approach required by ISO 14971 and expands on it with...
Read More

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.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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