Industry Perspectives - Design & Development
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Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
7/23/2024
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.
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Answer These Questions To Guide Your Prototyping Strategy
7/18/2024
This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm
6/6/2024
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.
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6 Essential Steps Of Forensic Medical Device Engineering
5/15/2024
Forensic medical device engineering is investigating and analyzing medical devices that have malfunctioned, failed, or caused adverse events. Here are 6 steps to resolve issues.
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Stop Inspecting For Quality — Start Building It.
5/10/2024
QC/QA activities that occur too late in the process or rely on a siloed team of inspectors can lead to significant waste and costs. Here’s the approach you should be using.
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A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices
5/8/2024
Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.
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AI-Enabled Medical Devices In India: Opportunities And Challenges
5/7/2024
India holds a lot of promise for the medical device sector. But can its regulations catch up with the with growing concerns about AI, security, and bias risks?
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.