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Medical devices
What Does DMA Measure: From Equipment Structure to E′·E″·tan δ Graphs
This article explains the structure and measuring principles of DMA equipment, along with examples of calculating storage modulus, loss modulus, and tan δ graphs.
Human tissues & biomaterials Revision of ISO 10993-6:2026, Basis for Selection of Control Materials in Implantation Tests This article explains the new selection criteria for control materials and related terminology, and outlines the method for reviewing the basis for selection through a hypothetical test plan.
Regulatory pathways Blood Sugar Claims for a Pain-Relief Device: Reviewing Medical Device Advertising This article distinguishes between efficacy claims beyond approval purposes using examples from the Ministry of Food and Drug Safety and explains how to verify product information against revised copies of advertising materials.
Environment & safety Laboratory Chemical Storage: Two SDS Sections to Connect Before Sorting Alphabetically This explains how to review the storage location of laboratory chemicals by linking the storage conditions and reaction hazards of SDS.
It covers checking product-specific information, virtual placement cases, and reasoning records.
Regulatory software Entering 10, Recording 100: Investigating Infusion Pump Input Errors This article explains methods for reviewing operational videos and comparing input events and screens based on FDA-released examples of infusion pump input errors.
Medical devices The Starting Point of Biological Evaluation: Contact Conditions of Skin Pads and Blood Pathways This article compares virtual skin pads and blood pathway tubes using the same silicone, explaining how to connect contact surfaces, usage time, frequency of use, and final product conditions to a biological evaluation plan.
Risk management & safety From a Dialysis Alarm to the Manufacturing Process: An MFDS Dialysis Tubing Case This article explores the investigation flow following alarm occurrences, micro holes in products of the same lot, mold abnormalities, and recall actions based on the MFDS dialysis tubing case.
QMS / ISO 13485 How Many of 1,000 Parts Should Be Inspected: Sampling Plan by Inspection Level and AQL This article compares the number of samples and acceptance/rejection criteria by inspection level and AQL using numerical examples from the current KS Q ISO 2859-1.
QMS / ISO 13485 Can the Sample Size of ISO 2859-1 be Applied to Developmental Performance Testing? This article distinguishes between lot acceptance sampling and the performance validation of new designs, explaining how to interpret the sample size in standards in conjunction with the scope, testing conditions, and basis for judgment.
Regulatory pathways Clinical Trial Device Inventory: Reconciling Receipt, Use, and Return This article explains how to divide the quantities of medical devices acquired by an institution, the number returned by the client, and the current inventory, using a hypothetical case for comparison between records and physical inventory.
Medical device research Sweat Sensor Flow Paths: Moving Old Samples Out and New Samples In This article organizes development questions explaining the differences between continuous flow and sequential sampling based on the 2019 sweat analysis patch research, and examines sample residuals and response delays.
Global markets EU Medical Device Language Requirements: Review by Country, User, and Information Type This article compares the conditions related to professional users in Germany and Austria, categorizing language requirements and translation review by separating manuals, safety information, and screen text.
Environment & safety Workplace Lighting: Reviewing Placement When Reflected Light Obscures Text This article explains the reasons why documents may not be clearly visible, even on bright work surfaces, by dividing the issues into illuminance and reflected glare, and summarizes methods for reviewing placements while maintaining proper working posture.
Risk management & safety Medical Device EMC: Planning Separately for Emissions and Immunity This article explains the process of distinguishing between the electromagnetic emissions from devices and their responses to external interference, as well as translating functionality-specific observation items into a test plan.
Human tissues & biomaterials Hydrogel Swelling Measurement: Reading Results from Dry Mass and Wet Mass This article explains the mass-based swelling assessment of bio-based hydrogels through calculation formulas, surface moisture treatment, time-based changes, and comparison conditions using a hypothetical case.
Regulatory software One Measurement, Different Times: Understanding UTC and Local Time This article explains the UTC offsets, date boundaries, and time field meanings necessary for comparing medical device software screens with server records, illustrated through a virtual case.
Regulatory pathways What Does Medical Device Classification Mean: Risk Classification and Performance Comparison Is a Class 4 medical device better? This article examines the meaning of classifications indicated by domestic medical device grades, and explains how to differentiate grades and performance in the product comparison table.
Medical device research Self-Shortening Surgical Sutures: Research into Pressure and Elasticity This article reviews the development perspective distinguishing movement and pulling force from the research on soft artificial muscle sutures that expand and contract with fluid pressure.
Global markets Same Model, Different Lots: How to Read UDI in Two Parts This article explains how to differentiate the DI and PI of the UDI set by the FDA and illustrates with a hypothetical receiving case how to read and record different lots of the same model.
Risk management & safety If Battery Level Is Displayed, Is Power Interruption Risk Managed? In the power review of home and portable medical devices, we distinguish between battery level display, operation duration, and the distinction between interruption and restart.
We explain the development team's review questions and data connection methods using a hypothetical measuring device case.
Human tissues & biomaterials Same Collagen, Same Material? Reviewing the Source and Evidence for Animal-Derived Materials Even if the ingredient names from two suppliers are the same, there are materials to verify.
This article examines how to read the sources, processes, and product application grounds through a hypothetical comparison of collagen ingredients.
Regulatory software What Requirements Were Verified in Software Testing? Even if requirement numbers are linked to test numbers, the verification scope may be empty.
This article explores how to connect expected behaviors, test conditions, actual records, and versions with a hypothetical case of sensor disconnection.
Regulatory pathways Comparing Current Approval Requirements Before Product Changes How do we connect the approval details that serve as criteria when reviewing changes to domestically manufactured items with the new specifications? We organize the review preparation with a hypothetical case of outer casing changes and a comparison table.
Medical devices Reading DSC Curves: Glass Transition, Melting, and Thermal History How do we distinguish between steps and peaks when comparing DSC results of polymer components? This article organizes the sequence of interpretation using three figures and a virtual lot comparison case.
Medical device research Sending Light and Reading with Sound: What to Confirm in Photoacoustic Patch Research Reading research that integrates laser and ultrasound receiving elements into a flexible patch.
It distinguishes the principles of operation, the scope of in vitro tests and human trials, and the limitations of external equipment connections and movements.
QMS / ISO 13485 If There Is a Calibration Certificate, Can We Inspect with That Equipment? This article distinguishes between confirming the calibration history and the actual purposes of measurement.
It organizes questions comparing the certificate with inspection conditions using a hypothetical scenario where the usage range has changed.
Environment & safety After Evacuation, Who Checks Who Came Out? This is an emergency evacuation preparation question to consider in workplaces where employees and visitors differ.
It examines personnel verification, absence of responsible individuals, and reporting systems through hypothetical cases.
Global markets If It Is Registered with the FDA, Is It an Approved Medical Device? Distinguishes between business registration, device listing, and the basis for product-specific decisions.
It organizes a virtual example dividing the order of reviewing overseas trade materials and confirming unresolved issues.
Medical devices Developers Use It Easily, But Do New Users? This article explores usability review questions considering users, usage environments, and device operations.
It connects observed behaviors from a hypothetical portable measuring device to design improvements and validation evidence.
QMS / ISO 13485 Defining the Scope of QMS Consulting: Preparing for the First Conversation This article outlines how to translate the request for an overall QMS into a specific scope of work.
It introduces questions and hypothetical consultation notes that clarify current state, priority tasks, necessary deliverables, and internal roles.
QMS / ISO 13485 Notification of Supplier Change: Records to Keep After Receiving the Email This practical guide connects the scope of changes, review basis, and applicable lots in a fictitious case of changing manufacturing location.
It contains practical questions and checklists to convert the supplier’s explanation into our product judgment records.
Medical devices Sterile Device Packaging: What to Check Beyond the Shipping Box This practical question connects the final packaging composition and distribution conditions with post-transportation verification items.
It examines the application scope of existing validation evidence through a hypothetical scenario involving a change in cushioning material.
Medical device research Ultrasound Sensors for the Abdomen: Development Challenges in Bladder Volume Research This article briefly introduces wearable ultrasound research, summarizing the principles of sensors, usage conditions, signal quality, and product validation with practical questions for the development team.
Environment & safety If You Have an SDS File, Check if You Can Open It On-Site The safety information of chemical substances in research and manufacturing environments does not end with file storage.
It organizes virtual cases that examine product identification, actual user access routes, and inaccessible situations, along with on-site verification notes.
Medical devices Better Performance Test Results? Check the Comparison Conditions First What should we check before interpreting differences in the performance test results of medical devices as design improvements? We will organize practical examples of comparing two reports and review notes, distinguishing differences in test subjects and methods.
Environment & safety Before Deciding on Personal Protective Equipment, Let's Look at Ways to Reduce Work Risks What should we look at to ensure safety measures in research and manufacturing sites do not stop at wearing personal protective equipment? This article organizes practical questions to verify the priority of risk reduction, the effectiveness of measures against abnormal working conditions.
QMS / ISO 13485 Latest Files and On-Site Usage: What to Verify After Document Revisions? Just because a file is labeled as final does not mean it is the document you can use right now.
This outlines how to distinguish between approval status and implementation timing, the target processes and field copies, and how to check the actual application of revised operational work standards.
QMS / ISO 13485 Handover of QMS Operations Even When the Responsible Person Changes The handover of quality tasks does not simply end with the transfer of folders.
This outlines how to connect current status, reasoning, next actions, a hypothetical case of supplier evaluation, and handover confirmation questions.
Global markets Entering the US and Europe: Key Authorization Questions to Address Before Translation This article summarizes the starting points for entering the US and Europe before translating domestic authorization materials.
It provides a practical checklist to clarify product definitions, market pathways, grounds for holding, and additional tasks.
Regulatory pathways Medical Device Authorization in Korea: Five Things to Define Before Searching for a Product Category This article organizes the necessary product information before reviewing the pathway for medical device approval in Korea.
It details how to specify the scope of review based on intended use, mechanism of action, composition, conditions of use, and differences from existing products.
Medical devices Three Questions for Understanding Medical Devices: Purpose of Use, Operating Principle, Performance This article examines why knowing the product name or specification alone is insufficient for understanding medical devices.
It divides the questions into purpose of use, operating principle, and performance, and connects product descriptions and verification questions using hypothetical measuring device examples.
Risk management & safety Medical Device Risk Management, What Should Follow the Analysis Table? We look at the practical tasks that remain after creating a risk management table.
From distinguishing risk factors and risk situations to the basis for control measures and connecting change and complaint records, explanations are provided with hypothetical examples.
QMS / ISO 13485 Maintaining a Quality System: Connecting Procedures with Actual Work What should be checked first when quality system documents exist but do not match actual operations? This article suggests practical methods for verifying the connection between procedures, responsibilities, records, and review results by following a single change task.
Regulatory software Lessons Learned in Translating Regulatory Judgments into Software: A Record of Q-Atelier Engine Design Real issues encountered when coding regulatory requirements as rules.
This record organizes the design of a system that conducts judgments outside the engine, which addresses reproducibility, rule versioning, and expert calibration.
QMS / ISO 13485 ISO 13485 §7.5.6: When Is Process Validation Required? This document organizes the criteria for identifying processes that cannot be verified through subsequent monitoring of outputs and the logic for determining the scope of validation from a practical perspective.
Human tissues & biomaterials Particle Size Analyzers and Rheometers: Two Tools for R&D in Bio-Material Medical Devices This article organizes the principles and reading methods of particle size analyzers (D10·D50·D90) and rheometers (G'·G'') from the perspective of developing bio-material medical devices such as hemostatic agents, bone grafts, and hydrogels.
Human tissues & biomaterials Revision of ISO 10993-6:2026, Basis for Selection of Control Materials in Implantation Tests This article explains the new selection criteria for control materials and related terminology, and outlines the method for reviewing the basis for selection through a hypothetical test plan.
Regulatory pathways Blood Sugar Claims for a Pain-Relief Device: Reviewing Medical Device Advertising This article distinguishes between efficacy claims beyond approval purposes using examples from the Ministry of Food and Drug Safety and explains how to verify product information against revised copies of advertising materials.
Environment & safety Laboratory Chemical Storage: Two SDS Sections to Connect Before Sorting Alphabetically This explains how to review the storage location of laboratory chemicals by linking the storage conditions and reaction hazards of SDS.
It covers checking product-specific information, virtual placement cases, and reasoning records.
Regulatory software Entering 10, Recording 100: Investigating Infusion Pump Input Errors This article explains methods for reviewing operational videos and comparing input events and screens based on FDA-released examples of infusion pump input errors.
Medical devices The Starting Point of Biological Evaluation: Contact Conditions of Skin Pads and Blood Pathways This article compares virtual skin pads and blood pathway tubes using the same silicone, explaining how to connect contact surfaces, usage time, frequency of use, and final product conditions to a biological evaluation plan.
Risk management & safety From a Dialysis Alarm to the Manufacturing Process: An MFDS Dialysis Tubing Case This article explores the investigation flow following alarm occurrences, micro holes in products of the same lot, mold abnormalities, and recall actions based on the MFDS dialysis tubing case.
QMS / ISO 13485 How Many of 1,000 Parts Should Be Inspected: Sampling Plan by Inspection Level and AQL This article compares the number of samples and acceptance/rejection criteria by inspection level and AQL using numerical examples from the current KS Q ISO 2859-1.
QMS / ISO 13485 Can the Sample Size of ISO 2859-1 be Applied to Developmental Performance Testing? This article distinguishes between lot acceptance sampling and the performance validation of new designs, explaining how to interpret the sample size in standards in conjunction with the scope, testing conditions, and basis for judgment.
Regulatory pathways Clinical Trial Device Inventory: Reconciling Receipt, Use, and Return This article explains how to divide the quantities of medical devices acquired by an institution, the number returned by the client, and the current inventory, using a hypothetical case for comparison between records and physical inventory.
Medical device research Sweat Sensor Flow Paths: Moving Old Samples Out and New Samples In This article organizes development questions explaining the differences between continuous flow and sequential sampling based on the 2019 sweat analysis patch research, and examines sample residuals and response delays.
Global markets EU Medical Device Language Requirements: Review by Country, User, and Information Type This article compares the conditions related to professional users in Germany and Austria, categorizing language requirements and translation review by separating manuals, safety information, and screen text.
Environment & safety Workplace Lighting: Reviewing Placement When Reflected Light Obscures Text This article explains the reasons why documents may not be clearly visible, even on bright work surfaces, by dividing the issues into illuminance and reflected glare, and summarizes methods for reviewing placements while maintaining proper working posture.
Risk management & safety Medical Device EMC: Planning Separately for Emissions and Immunity This article explains the process of distinguishing between the electromagnetic emissions from devices and their responses to external interference, as well as translating functionality-specific observation items into a test plan.
Human tissues & biomaterials Hydrogel Swelling Measurement: Reading Results from Dry Mass and Wet Mass This article explains the mass-based swelling assessment of bio-based hydrogels through calculation formulas, surface moisture treatment, time-based changes, and comparison conditions using a hypothetical case.
Regulatory software One Measurement, Different Times: Understanding UTC and Local Time This article explains the UTC offsets, date boundaries, and time field meanings necessary for comparing medical device software screens with server records, illustrated through a virtual case.
Regulatory pathways What Does Medical Device Classification Mean: Risk Classification and Performance Comparison Is a Class 4 medical device better? This article examines the meaning of classifications indicated by domestic medical device grades, and explains how to differentiate grades and performance in the product comparison table.
Medical device research Self-Shortening Surgical Sutures: Research into Pressure and Elasticity This article reviews the development perspective distinguishing movement and pulling force from the research on soft artificial muscle sutures that expand and contract with fluid pressure.
Global markets Same Model, Different Lots: How to Read UDI in Two Parts This article explains how to differentiate the DI and PI of the UDI set by the FDA and illustrates with a hypothetical receiving case how to read and record different lots of the same model.
Risk management & safety If Battery Level Is Displayed, Is Power Interruption Risk Managed? In the power review of home and portable medical devices, we distinguish between battery level display, operation duration, and the distinction between interruption and restart.
We explain the development team's review questions and data connection methods using a hypothetical measuring device case.
Human tissues & biomaterials Same Collagen, Same Material? Reviewing the Source and Evidence for Animal-Derived Materials Even if the ingredient names from two suppliers are the same, there are materials to verify.
This article examines how to read the sources, processes, and product application grounds through a hypothetical comparison of collagen ingredients.
Regulatory software What Requirements Were Verified in Software Testing? Even if requirement numbers are linked to test numbers, the verification scope may be empty.
This article explores how to connect expected behaviors, test conditions, actual records, and versions with a hypothetical case of sensor disconnection.
Regulatory pathways Comparing Current Approval Requirements Before Product Changes How do we connect the approval details that serve as criteria when reviewing changes to domestically manufactured items with the new specifications? We organize the review preparation with a hypothetical case of outer casing changes and a comparison table.
Medical devices Reading DSC Curves: Glass Transition, Melting, and Thermal History How do we distinguish between steps and peaks when comparing DSC results of polymer components? This article organizes the sequence of interpretation using three figures and a virtual lot comparison case.
Medical device research Sending Light and Reading with Sound: What to Confirm in Photoacoustic Patch Research Reading research that integrates laser and ultrasound receiving elements into a flexible patch.
It distinguishes the principles of operation, the scope of in vitro tests and human trials, and the limitations of external equipment connections and movements.
QMS / ISO 13485 If There Is a Calibration Certificate, Can We Inspect with That Equipment? This article distinguishes between confirming the calibration history and the actual purposes of measurement.
It organizes questions comparing the certificate with inspection conditions using a hypothetical scenario where the usage range has changed.
Environment & safety After Evacuation, Who Checks Who Came Out? This is an emergency evacuation preparation question to consider in workplaces where employees and visitors differ.
It examines personnel verification, absence of responsible individuals, and reporting systems through hypothetical cases.
Global markets If It Is Registered with the FDA, Is It an Approved Medical Device? Distinguishes between business registration, device listing, and the basis for product-specific decisions.
It organizes a virtual example dividing the order of reviewing overseas trade materials and confirming unresolved issues.
Medical devices Developers Use It Easily, But Do New Users? This article explores usability review questions considering users, usage environments, and device operations.
It connects observed behaviors from a hypothetical portable measuring device to design improvements and validation evidence.
QMS / ISO 13485 Defining the Scope of QMS Consulting: Preparing for the First Conversation This article outlines how to translate the request for an overall QMS into a specific scope of work.
It introduces questions and hypothetical consultation notes that clarify current state, priority tasks, necessary deliverables, and internal roles.
QMS / ISO 13485 Notification of Supplier Change: Records to Keep After Receiving the Email This practical guide connects the scope of changes, review basis, and applicable lots in a fictitious case of changing manufacturing location.
It contains practical questions and checklists to convert the supplier’s explanation into our product judgment records.
Medical devices Sterile Device Packaging: What to Check Beyond the Shipping Box This practical question connects the final packaging composition and distribution conditions with post-transportation verification items.
It examines the application scope of existing validation evidence through a hypothetical scenario involving a change in cushioning material.
Medical device research Ultrasound Sensors for the Abdomen: Development Challenges in Bladder Volume Research This article briefly introduces wearable ultrasound research, summarizing the principles of sensors, usage conditions, signal quality, and product validation with practical questions for the development team.
Environment & safety If You Have an SDS File, Check if You Can Open It On-Site The safety information of chemical substances in research and manufacturing environments does not end with file storage.
It organizes virtual cases that examine product identification, actual user access routes, and inaccessible situations, along with on-site verification notes.
Medical devices Better Performance Test Results? Check the Comparison Conditions First What should we check before interpreting differences in the performance test results of medical devices as design improvements? We will organize practical examples of comparing two reports and review notes, distinguishing differences in test subjects and methods.
Environment & safety Before Deciding on Personal Protective Equipment, Let's Look at Ways to Reduce Work Risks What should we look at to ensure safety measures in research and manufacturing sites do not stop at wearing personal protective equipment? This article organizes practical questions to verify the priority of risk reduction, the effectiveness of measures against abnormal working conditions.
QMS / ISO 13485 Latest Files and On-Site Usage: What to Verify After Document Revisions? Just because a file is labeled as final does not mean it is the document you can use right now.
This outlines how to distinguish between approval status and implementation timing, the target processes and field copies, and how to check the actual application of revised operational work standards.
QMS / ISO 13485 Handover of QMS Operations Even When the Responsible Person Changes The handover of quality tasks does not simply end with the transfer of folders.
This outlines how to connect current status, reasoning, next actions, a hypothetical case of supplier evaluation, and handover confirmation questions.
Global markets Entering the US and Europe: Key Authorization Questions to Address Before Translation This article summarizes the starting points for entering the US and Europe before translating domestic authorization materials.
It provides a practical checklist to clarify product definitions, market pathways, grounds for holding, and additional tasks.
Regulatory pathways Medical Device Authorization in Korea: Five Things to Define Before Searching for a Product Category This article organizes the necessary product information before reviewing the pathway for medical device approval in Korea.
It details how to specify the scope of review based on intended use, mechanism of action, composition, conditions of use, and differences from existing products.
Medical devices Three Questions for Understanding Medical Devices: Purpose of Use, Operating Principle, Performance This article examines why knowing the product name or specification alone is insufficient for understanding medical devices.
It divides the questions into purpose of use, operating principle, and performance, and connects product descriptions and verification questions using hypothetical measuring device examples.
Risk management & safety Medical Device Risk Management, What Should Follow the Analysis Table? We look at the practical tasks that remain after creating a risk management table.
From distinguishing risk factors and risk situations to the basis for control measures and connecting change and complaint records, explanations are provided with hypothetical examples.
QMS / ISO 13485 Maintaining a Quality System: Connecting Procedures with Actual Work What should be checked first when quality system documents exist but do not match actual operations? This article suggests practical methods for verifying the connection between procedures, responsibilities, records, and review results by following a single change task.
Regulatory software Lessons Learned in Translating Regulatory Judgments into Software: A Record of Q-Atelier Engine Design Real issues encountered when coding regulatory requirements as rules.
This record organizes the design of a system that conducts judgments outside the engine, which addresses reproducibility, rule versioning, and expert calibration.
QMS / ISO 13485 ISO 13485 §7.5.6: When Is Process Validation Required? This document organizes the criteria for identifying processes that cannot be verified through subsequent monitoring of outputs and the logic for determining the scope of validation from a practical perspective.
Human tissues & biomaterials Particle Size Analyzers and Rheometers: Two Tools for R&D in Bio-Material Medical Devices This article organizes the principles and reading methods of particle size analyzers (D10·D50·D90) and rheometers (G'·G'') from the perspective of developing bio-material medical devices such as hemostatic agents, bone grafts, and hydrogels.