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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...

Risk Management Series – Part 1: Prioritizing Risk Management Activities

May 9, 2020 | Risk Management

Forward: This second article in our series addresses a common risk analysis problem: prioritization. In large medical device companies, the email invitation to an FMEA session can strike fear (or at least dread) into the hearts of engineers and other members of the...

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News and Resources

RAPS Euro Convergence 2020 Summary

Jan 15, 2021 | News

The 2020 conference, or “convergence,” of European regulatory professionals that was originally to be held in October in Brussels instead took place virtually due to the pandemic. Even though it was conducted entirely online, the convergence covered a lot of...

ACMP Clinical and Regulatory Consulting, LLC (ACMP) is now part of MEDIcept Inc.

Jan 4, 2021 | News

Ashland, MA: MEDIcept Inc., an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), announces the acquisition of ACMP, a US-based privately held Clinical Research Organization (CRO) that provides...

Person Responsible for Regulatory Compliance

Dec 1, 2020 | Documents, News

As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...

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