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Articles by Jayet Moon
07.29.25 -- Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance
The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. Redefining Micro-Molding Excellence Through Capability & Sustainability Explore how Accumold leads in precision micro-molding, offering scalable, sustainable, and vertically integrated solutions for industries demanding high-quality micro components.
Cybersecurity Risk Management In Medical Devices Practical Implementation Of FDAs 2025 Final Guidance
By Jayet Moon The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” marks a major milestone in aligning medical device cybersecurity with regulatory expectations, emphasizing safety, effectiveness, and life cycle security.
Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance
By Jayet Moon The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," marks a major milestone in aligning medical device cybersecurity with regulatory expectations, emphasizing safety, effectiveness, and life cycle security.
09.14.24 -- Outsourced Pharma Best Of August
AUGUST'S BEST FEATURED EDITORIAL A Day In The Life Of A CMC Professional This CMC (chemistry, manufacturing and control) professional spends a good deal of time thinking about and interacting with his CDMOs. Through his experience, he knows that ineluctably some form of challenge will arise. Just another day at the office?
09.14.24 -- Pharmaceutical Online Best Of August
AUGUST'S BEST FEATURED EDITORIAL 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.
09.13.24 -- DSCSA Implementation Is Progressing, But More Complexity May Be Coming
Mabion Capacity Update July 2024: Large Molecule Development Explore our new installations in upstream development, new bioreactors, as well as downstream development and fill-finish. This state of the art EU-GMP certified facility is staffed by a team of 250 professionals, and capacity is now available. The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026.
09.12.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis
Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations. The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.
08.30.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024. In Defense Of The Full-Time Equivalent (FTE) "Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs.
08.27.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
By Jayet Moon and Arun Mathew The FDA released a new draft guidance, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, in early July. It provides guidance to industry and FDA staff on the purpose and content of a risk management tool for usability, a use-related risk analysis (URRA), that has recently gained lot of currency with the FDA.
07.09.24 -- Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | July 9, 2024 The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process. RFID For Med Devices: Identifying A Partner RFID is increasingly being used in medical devices.
Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm
By Jayet Moon and Arun Mathew In the highly regulated field of medical device development, ensuring product safety and efficacy while maintaining compliance with regulatory standards is paramount. Central to this is the design process that is founded on design controls, which provides a systematic framework for translating user needs into tangible product features while effectively managing risks.
06.01.24 -- May's Most Popular Articles & Solutions
The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance. The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
05.21.24 -- Long Live Design Controls: Navigating The Shift From QSR To QMSR
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | May 21, 2024 The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.
Long Live Design Controls: Navigating The Shift From QSR To QMSR
By Jayet Moon and Arun Mathew In the realm of medical device development and manufacturing, adherence to stringent regulatory standards is not just a legal requirement, it’s also a fundamental aspect of ensuring product safety and efficacy. For years, the FDA's design controls under 21 CFR Part 820 (Quality Systems Regulation [QSR]) have served as a cornerstone for guiding manufacturers through the process of designing and design transfer of medical devices.
04.06.24 -- March's Most Popular Articles & Solutions
On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
03.12.24 -- New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis
On February 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by February 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis
By Edwin Bills, Christie Johnson, and Jayet Moon On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. This regulation marks a pivotal transition from the guidelines previously stated in 21 CFR 820.5, forging a pathway toward an integrated approach that aligns with global standards.
07.01.23 -- June's Most Popular Articles & Solutions
By Edwin Bills and Christie Johnson The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.
06.01.23 -- The Role Of Failure Mode In ISO 14971
By Jayet Moon, author of the book In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.
The Role Of Failure Mode In ISO 14971:2019's Hazard-Based Approach
By Jayet Moon, author of the book Foundations of Quality Risk Management In the context of ISO 14971:20191 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs (failure modes and effects analyses), especially since this standard takes a hazard-based approach.
08.19.22 -- FDA Seeks Comment On Conducting Remote Regulatory Assessments
By Mark Durivage, Quality Systems Compliance LLC The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on September 30, 2022.
06.01.22 -- EU MDR's Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
By Lakshmi Sankar and Belinda Griffin, PA Consulting The answer to the call for greater collaboration and interoperability lies in open source, a software development model in which copyrighted source code is made available via a free license for possible modification and redistribution to any interested user or developer. This creates a model that encourages open collaboration for the benefit of patients.
EU MDR's Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
By Jayet Moon and Veronica Stephens European Medical Device regulations define “benefit-risk determination” as "the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer." The regulations refer to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I.
EU MDR's Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
By Jayet Moon and Veronica Stephens European Medical Device regulations define “benefit-risk determination” as "the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer." The regulations refer to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I.
FMECA: Relevance In Context Of ISO 14971 & EU MDR Compliance
By Jayet Moon, author of the book Foundations of Quality Risk Management Failure modes and effects and criticality analysis (FMECA), a tool developed by U.S. military, has been around since World War II, when it was used to identify and reduce component reliability-related risks for rocket parts (see MIL-P-1629, published in 1949). From then on, NASA adopted the method and successfully used it for the Apollo manned spaceflight program (RA-006-013-1A, published in 1966).
11.11.21 -- The Essential Components Of A Sterility Assurance Program
By Jayet Moon, Veronica Stephens, and Kylee Rogers In Part 1 of this two-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk. By Crystal M.
11.04.21 -- An Introduction To Biopharma Facility Design & Layout
By Herman & Erich Bozenhardt This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
10.21.21 -- A Quantitative Benefit-Risk Analysis Using Real World Data
By Jayet Moon, Veronica Stephens, and Kylee Rogers In Part 1 of this two-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
10.15.21 -- Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data
Article | By Sandeep Kumar and Billy Edwards, Thermo Fisher Scientific The case studies presented in this paper highlight Thermo Fisher Scientific’s spray-drying experience and our dedication to helping manufacturers overcome obstacles that could slow your path to market. Article | By Robert Smith, CAI This article will look at how a greater understanding of failure will help your organization develop the right mindset to achieve best-in-class proactive maintenance performance levels.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
By Jayet Moon, Veronica Stephens, and Kylee Rogers In the previous article, we presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
By Jayet Moon, Veronica Stephens, and Kylee Rogers In the previous article, we presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
By Jayet Moon, Veronica Stephens, and Kylee Rogers In the previous article, we presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
By Jayet Moon, Veronica Stephens, and Kylee Rogers In the previous article, we presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
By Jayet Moon, Veronica Stephens, and Kylee Rogers In the previous article, we presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
By Jayet Moon, Veronica Stephens, and Kylee Rogers Integrative risk assessments in medical applications involve more than qualitative or quantitative specific line item-based risk assessment of occurrence and severity.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
By Jayet Moon, Veronica Stephens, and Kylee Rogers Integrative risk assessments in medical applications involve more than qualitative or quantitative specific line item-based risk assessment of occurrence and severity.
07.22.21 -- New U.S. Legislation Creates Biosimilars Momentum
By S. Ropka, Ph.D., T. Mathias, and R. Auroprem, Axinn, Veltrop & Harkrider LLP Most biosimilars (follow-on biologics products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.
5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
By Jayet Moon, author of the book Foundations of Quality Risk Management The methods and tools related to lean manufacturing or the Toyota Production System[1] have gained much currency over the past decades after the global success of Japanese companies since the 1970s. By now, many professionals are familiar with words such as Kaizen, Kanban, 5S, Poke Yoke, and Just-in-Time (JIT).
5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
By Jayet Moon, author of the book Foundations of Quality Risk Management The methods and tools related to lean manufacturing or the Toyota Production System[1] have gained much currency over the past decades after the global success of Japanese companies since the 1970s. By now, many professionals are familiar with words such as Kaizen, Kanban, 5S, Poke Yoke, and Just-in-Time (JIT).
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management
By Veronica Stephens and Jayet Moon We know you’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. Safety risk management is the identification, analysis, and elimination (and/or mitigation to an acceptable or tolerable level) of the hazards, as well as the subsequent risks, that threaten the intended use of the medical device.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending
By Jayet Moon, author of the book Foundations of Quality Risk Management As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management
By Jayet Moon, author of the book Foundations of Quality Risk Management As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach
By Jayet Moon, author of the book Foundations of Quality Risk Management As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1.
Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation
By Jayet Moon, author of the book Foundations of Quality Risk Management As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1.
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