Conclusion: Which Risk Management Tools Work Best Together in MedTech?
SIFo Medical – Supporting MedTech Companies
Conclusion: Which Risk Management Tools Work Best Together in MedTech?
0:50
What is a Fault Tree Analysis (FTA)?
SIFo Medical – Supporting MedTech Companies
What is a Fault Tree Analysis (FTA)?
0:45
FMEA Explained: Failure Mode and Effects Analysis in MedTech
SIFo Medical – Supporting MedTech Companies
FMEA Explained: Failure Mode and Effects Analysis in MedTech
0:57
HAZOP Explained: What Is a Hazard and Operability Study?
SIFo Medical – Supporting MedTech Companies
HAZOP Explained: What Is a Hazard and Operability Study?
0:35
What Does a Risk Analysis Do? | MedTech Explained
SIFo Medical – Supporting MedTech Companies
What Does a Risk Analysis Do? | MedTech Explained
1:05
ETA Explained: What Is Event Tree Analysis in Risk Management?
SIFo Medical – Supporting MedTech Companies
ETA Explained: What Is Event Tree Analysis in Risk Management?
0:34
HACCP Explained: Hazard Analysis and Critical Control Points in Risk Management
SIFo Medical – Supporting MedTech Companies
HACCP Explained: Hazard Analysis and Critical Control Points in Risk Management
0:50
Essential Tools for Effective Risk Management
SIFo Medical – Supporting MedTech Companies
Essential Tools for Effective Risk Management
1:42
Intro: Risk Management Tools in MedTech
SIFo Medical – Supporting MedTech Companies
Intro: Risk Management Tools in MedTech
0:48
Fazit: Welche Kombination von Werkzeugen ist im Risikomanagement der Medizintechnik sinnvoll?
SIFo Medical – Supporting MedTech Companies
Fazit: Welche Kombination von Werkzeugen ist im Risikomanagement der Medizintechnik sinnvoll?
0:50
FMEA: Failure Mode and Effects Analysis
SIFo Medical – Supporting MedTech Companies
FMEA: Failure Mode and Effects Analysis
0:57
Risikoanalyse in der Medizintechnik
SIFo Medical – Supporting MedTech Companies
Risikoanalyse in der Medizintechnik
1:07
FTA: Fault Tree Analysis
SIFo Medical – Supporting MedTech Companies
FTA: Fault Tree Analysis
0:45
ETA: Event Tree Analysis
SIFo Medical – Supporting MedTech Companies
ETA: Event Tree Analysis
0:34
HAZOP: Hazard and Operability Study
SIFo Medical – Supporting MedTech Companies
HAZOP: Hazard and Operability Study
0:35
HACCP: Hazard Analysis and Critical Control Points
SIFo Medical – Supporting MedTech Companies
HACCP: Hazard Analysis and Critical Control Points
0:50
Welche Werkzeuge benötigen wir im Risikomanagement?
SIFo Medical – Supporting MedTech Companies
Welche Werkzeuge benötigen wir im Risikomanagement?
1:42
Intro: Werkzeuge im Risikomanagement in der Medizintechnik
SIFo Medical – Supporting MedTech Companies
Intro: Werkzeuge im Risikomanagement in der Medizintechnik
0:48
Would you recommend SIFo Medical? | Feedback Fresenius Kabi
SIFo Medical – Supporting MedTech Companies
Would you recommend SIFo Medical? | Feedback Fresenius Kabi
0:32
Feedback from elm-plastic GmbH | Medical Device Risk Management
SIFo Medical – Supporting MedTech Companies
Feedback from elm-plastic GmbH | Medical Device Risk Management
3:22
What Is the Difference Between Validation vs. Verification?
SIFo Medical – Supporting MedTech Companies
What Is the Difference Between Validation vs. Verification?
2:45
Lieferantenmanagement in der Medizintechnik | Webinar vom 26.09.24
SIFo Medical – Supporting MedTech Companies
Lieferantenmanagement in der Medizintechnik | Webinar vom 26.09.24
38:01
Test Method Validation in MedTech: Your Practical Step-by-Step Guide
SIFo Medical – Supporting MedTech Companies
Test Method Validation in MedTech: Your Practical Step-by-Step Guide
1:41
How To Analyze Variable Data Using a Statistical Tolerance Interval (with Minitab) | MedTech
SIFo Medical – Supporting MedTech Companies
How To Analyze Variable Data Using a Statistical Tolerance Interval (with Minitab) | MedTech
3:10
How To Interpret Statistical Tolerance Intervals | MedTech Statistics
SIFo Medical – Supporting MedTech Companies
How To Interpret Statistical Tolerance Intervals | MedTech Statistics
3:07
Risk Based Sample Size for Variable Data | MedTech Statistics
SIFo Medical – Supporting MedTech Companies
Risk Based Sample Size for Variable Data | MedTech Statistics
4:40
How To Come Up With a Risk Based Sample Size for Attribute Data | MedTech Statistics
SIFo Medical – Supporting MedTech Companies
How To Come Up With a Risk Based Sample Size for Attribute Data | MedTech Statistics
2:35
SIFo Medical – Quality and Supplier Management for Medical Device Manufacturers
SIFo Medical – Supporting MedTech Companies
SIFo Medical – Quality and Supplier Management for Medical Device Manufacturers
0:32
Process Validation Requirements: Is Periodic Re-Validation Required in MedTech?
SIFo Medical – Supporting MedTech Companies
Process Validation Requirements: Is Periodic Re-Validation Required in MedTech?
0:34
Test Method Validation Standards and Guidelines | Medical Devices
SIFo Medical – Supporting MedTech Companies
Test Method Validation Standards and Guidelines | Medical Devices
0:55
Can Destructive Test Methods be Validated? | Medical Device Manufacturing
SIFo Medical – Supporting MedTech Companies
Can Destructive Test Methods be Validated? | Medical Device Manufacturing
0:45
Does a Standard Test Method Need to be Validated? | MedTech Test Method Validation
SIFo Medical – Supporting MedTech Companies
Does a Standard Test Method Need to be Validated? | MedTech Test Method Validation
0:40
Performance Qualification (PQ) in MedTech – How many runs do you have to produce for a PQ?
SIFo Medical – Supporting MedTech Companies
Performance Qualification (PQ) in MedTech – How many runs do you have to produce for a PQ?
1:05
Gage R&R in Medical Device Production – Explained Simply!
SIFo Medical – Supporting MedTech Companies
Gage R&R in Medical Device Production – Explained Simply!
1:14
Test Methods – Variable or Attribute Data & Destructive or Non-Destructive Test Methods
SIFo Medical – Supporting MedTech Companies
Test Methods – Variable or Attribute Data & Destructive or Non-Destructive Test Methods
0:31
Does a Test Method Validation need an Installation Qualification? | Medical Device Production
SIFo Medical – Supporting MedTech Companies
Does a Test Method Validation need an Installation Qualification? | Medical Device Production
0:30
Test Method Validation for Medical Devices – What does a TMV do?
SIFo Medical – Supporting MedTech Companies
Test Method Validation for Medical Devices – What does a TMV do?
0:37
Requirements for Test Method Validation – Where to find them? | Medical Device Production
SIFo Medical – Supporting MedTech Companies
Requirements for Test Method Validation – Where to find them? | Medical Device Production
0:58
Installation Qualification – Where to Find the Requirements? | MedTech
SIFo Medical – Supporting MedTech Companies
Installation Qualification – Where to Find the Requirements? | MedTech
0:44
Statistical Tolerance Interval – What is it and why is it relevant in MedTech?
SIFo Medical – Supporting MedTech Companies
Statistical Tolerance Interval – What is it and why is it relevant in MedTech?
0:32
AQL vs. RQL – What's The Difference And Why Does it Matter in MedTech?
SIFo Medical – Supporting MedTech Companies
AQL vs. RQL – What's The Difference And Why Does it Matter in MedTech?
0:44
What is an Installation Qualification (IQ)? | Medical Device Production
SIFo Medical – Supporting MedTech Companies
What is an Installation Qualification (IQ)? | Medical Device Production
0:48
What is the Typical Content of an Installation Qualification (IQ)?
SIFo Medical – Supporting MedTech Companies
What is the Typical Content of an Installation Qualification (IQ)?
0:46
What Guidelines are available for Process Validation?
SIFo Medical – Supporting MedTech Companies
What Guidelines are available for Process Validation?
0:48
Installation Qualification Checklist – Where to Get Information From?
SIFo Medical – Supporting MedTech Companies
Installation Qualification Checklist – Where to Get Information From?
0:30
Does an Operational Qualification (OQ) always have 2 runs? | MedTech
SIFo Medical – Supporting MedTech Companies
Does an Operational Qualification (OQ) always have 2 runs? | MedTech
0:37
Operational Qualification: Equipment OQ vs. Process OQ | MedTech
SIFo Medical – Supporting MedTech Companies
Operational Qualification: Equipment OQ vs. Process OQ | MedTech
1:28
Qualified Limits vs. Validated Limits in Operational Qualification (OQ) – What’s the Difference?
SIFo Medical – Supporting MedTech Companies
Qualified Limits vs. Validated Limits in Operational Qualification (OQ) – What’s the Difference?
0:27
Checklist Operational Qualification (OQ) – What you need to start!
SIFo Medical – Supporting MedTech Companies
Checklist Operational Qualification (OQ) – What you need to start!
0:45
Operational Qualification – How Many Samples Do You Need? | MedTech
SIFo Medical – Supporting MedTech Companies
Operational Qualification – How Many Samples Do You Need? | MedTech
1:13
Statistics Requirements in MedTech: Can You Use Statistics in the Medical Device Industry?
SIFo Medical – Supporting MedTech Companies
Statistics Requirements in MedTech: Can You Use Statistics in the Medical Device Industry?
0:49
How to Justify a Sample Size in MedTech
SIFo Medical – Supporting MedTech Companies
How to Justify a Sample Size in MedTech
0:52
Confidence Statements in MedTech – What is a Confidence Statement & what does it mean?
SIFo Medical – Supporting MedTech Companies
Confidence Statements in MedTech – What is a Confidence Statement & what does it mean?
0:50
Variable vs. Attribute Data – What's the difference? | MedTech Statistics
SIFo Medical – Supporting MedTech Companies
Variable vs. Attribute Data – What's the difference? | MedTech Statistics
0:43
Where to get the limits for the Operational Qualification (OQ) runs from?
SIFo Medical – Supporting MedTech Companies
Where to get the limits for the Operational Qualification (OQ) runs from?
0:40
What is an Operational Qualification (OQ) in MedTech?
SIFo Medical – Supporting MedTech Companies
What is an Operational Qualification (OQ) in MedTech?
1:07
When do I need to perform Installation Qualification when manufacturing medical devices?
SIFo Medical – Supporting MedTech Companies
When do I need to perform Installation Qualification when manufacturing medical devices?
1:26
Do I Have to Validate Manual Processes in Medical Technology?
SIFo Medical – Supporting MedTech Companies
Do I Have to Validate Manual Processes in Medical Technology?
0:41
Where Can I Find the Requirements for Process Validation?
SIFo Medical – Supporting MedTech Companies
Where Can I Find the Requirements for Process Validation?
0:59
What are the Different Phases of a Process Validation? | Medical Device Manufacturing
SIFo Medical – Supporting MedTech Companies
What are the Different Phases of a Process Validation? | Medical Device Manufacturing
0:49
When to Validate Processes in MedTech?
SIFo Medical – Supporting MedTech Companies
When to Validate Processes in MedTech?
0:39
What is a Validation Masterplan and is it required by regulations?
SIFo Medical – Supporting MedTech Companies
What is a Validation Masterplan and is it required by regulations?
0:44