Articles From Our Expert Network
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4 Steps To Kick Off Your Mold Production Project For Success
1/18/2021
Zachi Fizik of ZF Consulting has been involved with injection molds production since the early 1990s. In the first article in this two-part article series, he'll detail the four milestones that are relevant and necessary for all mold production projects, no matter how tight your budget is or how quickly your deadline looms.
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Using Production And Postmarket Data To Validate FMEA Assumptions
1/15/2021
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
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Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”?
1/13/2021
Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis.
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Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues
1/8/2021
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
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Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending
1/6/2021
Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.
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Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management
12/22/2020
The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.
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Tips For Building A Voluntary QA Culture In A 2021 COVID World
12/21/2020
As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.
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Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach
12/15/2020
Jayet Moon continues his four-part series on risk-based postmarket surveillance in the age of the EU Medical Device Regulations (MDR) with Part 2, which delves into the systems approach. Such an approach gives due consideration to process interfaces with other organizational functions and knowledge management. It would not only make compliance to EU MDR easy but also make the organizational processes much more effective and efficient.
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Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation
12/11/2020
Jayet Moon begins this four-part series on risk-based postmarket surveillance (PMS) in the age of EU MDR by delving into the incident investigation. Such investigations are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. By looking into the Who? What? When? Where? Why? and How? of serious events related to your device, you'll be able to provide answers to regulatory bodies.
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Fluid Management Equipment Market Poised For Growth In Europe
12/7/2020
In the gynecology market, as the use of hysteroscopes and other less invasive methods increases, more procedures will require the use of fluid management equipment. Notably, there has been significant growth in the sales of both capital equipment and tubing for fluid management during hysteroscopic procedures. This article discusses the current and future fluid management market in Europe.