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QA/QC

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QA/QC
Changes to CFRs Will Focus on How Manufacturers Use Risk ManagementChanges to CFRs Will Focus on How Manufacturers Use Risk Management

A look at how to better align medical device quality management system requirements with ISO 13485:2016.

bySusan Shepard
Oct 2, 2023|
4 Min Read
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Regulatory & Quality
Diving into FDA’s QMSR Alignment with ISO 13485Diving into FDA’s QMSR Alignment with ISO 13485
byOmar Ford
Sep 8, 2023
4 Min Read
Check list
Manufacturing
Achieving Medical Device Quality Management System ExcellenceAchieving Medical Device Quality Management System Excellence
Jul 20, 2023
10 Min Read
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QA/QC
The World of Quality Control Has Changed for Medical Device ManufacturersThe World of Quality Control Has Changed for Medical Device Manufacturers
byMichael Simms, Stefan Siwiecki
Oct 27, 2021
3 Min Read
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Manufacturing
Albéa Manufactures Plastic Parts for Diagnostic Tests and More Supplier NewsAlbéa Manufactures Plastic Parts for Diagnostic Tests and More Supplier News
byMDDI Staff
Jan 29, 2021
6 Slides
quality compliance
QA/QC
Struggling with Quality Compliance? This Pilot Study Is for YouStruggling with Quality Compliance? This Pilot Study Is for You
byAmanda Pedersen
Jul 29, 2020
3 Min Read
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QA/QC
Three Ways Healthcare QA Helps Improve Patient Outcomes
Three Ways Healthcare QA Helps Improve Patient Outcomes
Jul 14, 2020
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4 Min Read
byYana Yelina
Velentium making ventilator test stands
IVD
Behind the Scenes of Building Ventilator Testing Systems During a Pandemic
Behind the Scenes of Building Ventilator Testing Systems During a Pandemic
Jun 19, 2020
|
11 Min Read
byAmanda Pedersen
Medtronic Faces Class I Recall Over Insulin Pumps
Regulatory & Quality
Medtronic Faces Class I Recall Over Insulin Pumps
Medtronic Faces Class I Recall Over Insulin Pumps
Feb 14, 2020
|
1 Min Read
byOmar Ford
No More Wasted Lots: Improved Connectivity, Tracking, and CAPA Through Digitization
Software
No More Wasted Lots: Improved Connectivity, Tracking, and CAPA Through Digitization
No More Wasted Lots: Improved Connectivity, Tracking, and CAPA Through Digitization
Dec 11, 2019
|
8 Min Read
byMatthew M. Lowe
Tips for When to Consider Legal Review of Quality System Investigations
Equipment
Tips for When to Consider Legal Review of Quality System Investigations
Tips for When to Consider Legal Review of Quality System Investigations
Sep 5, 2019
|
5 Min Read
byAllison Fulton
Boosting Medical Device Quality and Profitability via a Common Product Model
Design & Engineering
Boosting Medical Device Quality and Profitability via a Common Product Model
Boosting Medical Device Quality and Profitability via a Common Product Model
Aug 26, 2019
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6 Min Read
byLouis Columbus, Michael Buchli
Could Managing Quality Data in the Cloud Reduce Deviations?
Software
Could Managing Quality Data in the Cloud Reduce Deviations?
Could Managing Quality Data in the Cloud Reduce Deviations?
Jul 25, 2019
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6 Min Read
byDaphne Allen
Labeling Recall: Automation is the Answer
Packaging
Labeling Recall: Automation is the Answer
Labeling Recall: Automation is the Answer
May 17, 2019
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4 Min Read
byCraig Jones
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
Automation
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
Dec 5, 2018
|
5 Min Read
byCarlos Meléndez
Applying Quality Management Best Practices for Medtech
Regulatory & Quality
Applying Quality Management Best Practices for Medtech
Applying Quality Management Best Practices for Medtech
Oct 17, 2018
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11 Min Read
byAnthony Parise, Louis Columbus
Continuous Quality: FDA’s Goal for the Case for Quality Program
Regulatory & Quality
Continuous Quality: FDA’s Goal for the Case for Quality Program
Continuous Quality: FDA’s Goal for the Case for Quality Program
Oct 5, 2018
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2 Min Read
bySusan Shepard
CQOE and Funky Math
Software
CQOE and Funky Math
CQOE and Funky Math
Apr 10, 2018
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5 Min Read
byWilliam A. Hyman
Stop Doing This to Improve Your Device Manufacturing Process: Part 1
Regulatory & Quality
Stop Doing This to Improve Your Device Manufacturing Process: Part 1
Stop Doing This to Improve Your Device Manufacturing Process: Part 1
Oct 11, 2017
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10 Min Read
byCushing Hamlen, Bradley Fern
Hospital Disinfectants: Why You Should Reconsider Your Materials Testing Approach
Materials
Hospital Disinfectants: Why You Should Reconsider Your Materials Testing Approach
Hospital Disinfectants: Why You Should Reconsider Your Materials Testing Approach
Jul 5, 2017
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5 Min Read
byDaphne Allen
Medtronic Exec: How to Move Past Compliance to Quality
QA/QC
Medtronic Exec: How to Move Past Compliance to Quality
Medtronic Exec: How to Move Past Compliance to Quality
Nov 5, 2013
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13 Min Read
byQmed Staff
Outsourcing Outlook on Extrusion Services: Q&A
QA/QC
Outsourcing Outlook on Extrusion Services: Q&A
Outsourcing Outlook on Extrusion Services: Q&A
Mar 8, 2013
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2 Min Read
byBob Michaels
Q&A with Bill Murray, CEO of Envoy Medical
QA/QC
Q&A with Bill Murray, CEO of Envoy Medical
Q&A with Bill Murray, CEO of Envoy Medical
Nov 5, 2012
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14 Min Read
byJohn Conroy
Medtech Executive Q&A: Ryan Ashton, Great Basin
QA/QC
Medtech Executive Q&A: Ryan Ashton, Great Basin
Medtech Executive Q&A: Ryan Ashton, Great Basin
Jun 22, 2012
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16 Min Read
byJohn Conroy
Tracking and Transparency: The Keys to Improving Medical Device Quality
QA/QC
Tracking and Transparency: The Keys to Improving Medical Device Quality
Tracking and Transparency: The Keys to Improving Medical Device Quality
Apr 27, 2012
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8 Min Read
byBob Michaels
Q&A with Paul Fearis, CEO of Clinvue
QA/QC
Q&A with Paul Fearis, CEO of Clinvue
Q&A with Paul Fearis, CEO of Clinvue
Apr 19, 2012
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26 Min Read
byJohn Conroy
Quality Issues in Asia, Shortage of Suppliers Impact Medical Device Batteries
QA/QC
Quality Issues in Asia, Shortage of Suppliers Impact Medical Device Batteries
Quality Issues in Asia, Shortage of Suppliers Impact Medical Device Batteries
Feb 22, 2012
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2 Min Read
The MX Q&A: Clyde Pratt, Kinamed
QA/QC
The MX Q&A: Clyde Pratt, Kinamed
The MX Q&A: Clyde Pratt, Kinamed
Feb 21, 2012
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20 Min Read
byJohn Conroy
The MX Q&A: Skip Goode, Pathfinder Therapeutics
QA/QC
The MX Q&A: Skip Goode, Pathfinder Therapeutics
The MX Q&A: Skip Goode, Pathfinder Therapeutics
Dec 14, 2011
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16 Min Read
byJohn Conroy
The MX Q&A: Chris Hobson, Isis Biopolymer
QA/QC
The MX Q&A: Chris Hobson, Isis Biopolymer
The MX Q&A: Chris Hobson, Isis Biopolymer
Nov 18, 2011
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17 Min Read
byJohn Conroy
The MX Q&A: Dan Gladney, Lanx
QA/QC
The MX Q&A: Dan Gladney, Lanx
The MX Q&A: Dan Gladney, Lanx
Aug 24, 2011
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10 Min Read
byJohn Conroy
The MX Q&A: Richard Meelia, Covidien
QA/QC
The MX Q&A: Richard Meelia, Covidien
The MX Q&A: Richard Meelia, Covidien
May 18, 2011
|
14 Min Read
byJohn Conroy
Human Error and Quality Control in Medical Devices
QA/QC
Human Error and Quality Control in Medical Devices
Human Error and Quality Control in Medical Devices
Apr 25, 2011
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11 Min Read
byMax Sherman, Sherman Consulting Services Inc.
The MX Q&A: Hugh Martin, Pacific Biosciences
QA/QC
The MX Q&A: Hugh Martin, Pacific Biosciences
The MX Q&A: Hugh Martin, Pacific Biosciences
Feb 23, 2011
|
15 Min Read
byJohn Conroy
The MX Q&A: John McDonough, T2 Biosystems
QA/QC
The MX Q&A: John McDonough, T2 Biosystems
The MX Q&A: John McDonough, T2 Biosystems
Dec 27, 2010
|
14 Min Read
byJohn Conroy

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