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Risk Management Series – Article 7 Part A: Determining Risk Acceptability

Mar 15, 2021 | Risk Management

In our last two articles, Part 5: Assigning Harms and Severity and Part 6: Estimating Probability of Occurrence, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes...

Risk Management Series – Part 6: Estimating Probability of Occurrence

Oct 15, 2020 | Risk Management

In our last article, Part 5: Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and...

Risk Management Series – Part 5: Assigning Harms and Severity

Aug 9, 2020 | Risk Management, Documents

Introduction One of the most challenging elements of risk analysis is the assignment of Harms and Severities to a particular hazardous situation. On the surface, describing the consequences of the sequence of actions that lead to exposure to a hazard seems pretty...

Risk Management Series – Part 4: Key Terms

Jul 9, 2020 | Risk Management

Introduction Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some...

Risk Management Series – Part 3: Transferring Risks from Fault Trees to FMEAs

Jun 9, 2020 | Risk Management

Foreword In our last article, Part 2: Using Fault Trees to Focus and Simplify Risk Analysis, we described the basic approach for conducting a Fault Tree Analysis (FTA) and the benefits of using FTA to conduct a comprehensive analysis of the causes of device failures...

Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis

Jun 5, 2020 | Risk Management

In our previous article (Part 1: Prioritizing Risk Management Activities), we described an approach for identifying the design element(s) or process stages(s) to prioritize when conducting a comprehensive risk analysis. This prioritization helps to ensure that the...

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News and Resources

QSMR: Expert Analysis - Part 1 Whitepaper

Clinical White Paper - Patient Reported Outcomes 5-4-22

MEDIcept Inc. appoints Kim Trautman, former Associate Director of International Affairs at FDA, as Managing Director and Vice President

Feb 1, 2022 | News

Ashland MA, February 1, 2022. MEDIcept Inc. announced today that Kim Trautman has been appointed as Managing Director and Vice President of the company. An experienced medical device, IVD, and combination product expert, Trautman worked at the US Food and Drug...

Medical Device Regulatory Changes in the Post-Brexit UK

Dec 15, 2021 | News

If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...

Supply Chain Woes: COVID and Medical Device Manufacturing

Oct 18, 2021 | News

The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving. Medical device manufacturing is just one of the many industrial...

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