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Just wanted to remind you about the documents that are available to download in the Document Repository; please click here to get to the Document Repository.

Design Verification

Design Verification: This paper explores the use and misuse of Design Verification and how device manufacturers can get the most out of their verification efforts.

Risk Management

Risk Management Series Introduction – Beyond FMEA:
Too often, when medical device companies think about risk management, they think of just two things: Regulatory requirement and FMEAs.

Regulations are not the only reason that it’s important to understand, control, and monitor risks; and FMEAs are not the only tool to do it. This paper kicks off our series on risk management and sets the stage for further discussions.

Risk Management Series Part 2: Prioritizing Risk Management Activities

A key element of the risk management process is to focus the team’s attention on reducing risk that could cause serious harm, but many times risk management teams get lost in the weeds of the risk management process and lose sight of the key issues. This paper provides an approach to help set risk management priorities.

Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis
Many risk management teams jump immediately into the process of filling out the lines of FMEAs before they develop a strong understand of the system they are analyzing. While Fault Tree Analysis (FTA) will not solve all of you risk analysis problems, it will help you to better understand the system you are analyzing and help you to focus the system elements that are most important.

Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs
One argument against using Fault Tree Analysis (FTA) is that your company’s risk management procedure requires an FMEA and there’s no way to link the FMEA and the FTA. Not true. In fact, the FTA will help you prepare a better FMEA that addresses important risks and meets internal company requirements.

Risk Management Series – Part 5: Assessing Severity
One of the most challenging elements of risk analysis is the assignment of a Severity score to a particular hazard or failure mode. On the surface, assigning a Severity score seems pretty straight-forward.  Unfortunately, like most things, the devil is in the details. This paper will help you assess severity more effectively.

Risk Management Series – Part 6: Estimating Probability of Occurrence
Understanding the components of the “Probability of Occurrence of Harm” is critical to understanding your risks.  If your team members each have their own definitions, it will be hard to achieve alignment. This paper lays out a clear approach for estimating occurrence.

Risk Management Series – Part 7: Determining Risk Acceptability – Part A
To kick off this two-part discussion, this paper describes the standard (ISO 14971) approach for assessing risk acceptability – and addressing the RPN questions – setting the stage for a more detailed discussion of the challenges in Part B.

Risk Management Series – Part 7: Determining Risk Acceptability – Part B
The standard risk management approach (ISO 14971) for assessing risk acceptability can get a little complicated. This paper describes some of the key challenges to implementing the standard approach and what to look out for.

Clinical Evaluation Reports

Clinical Evaluation Reports – Tying it All Together (Article 1 of 3)
Clinical evaluation reports (CERs) are required for all CE marked devices – yes, all of them. This article kicks off a series on how best to implement the guidance provided in MEDDEV. 2.7.1. Rev 3.

Clinical Evaluation Reports – Tying it All Together (Article 2 of 3)

Building on our previous article, this article describes key issues to consider when conducting literature reviews, collecting internal/external safety data, and assessing risk management documents.

Clinical Evaluation Reports – Tying it All Together (Article 3 of 3)
This final article in the series provides an outline for the clinical evaluation report that will allow you to tie all the elements together.