What does “as appropriate” mean?
Medical Device HQ
What does “as appropriate” mean?
0:55
Short course on design control for medical devices
Medical Device HQ
Short course on design control for medical devices
18:11
Are all medical device audit findings nonconformities?
Medical Device HQ
Are all medical device audit findings nonconformities?
0:50
Carpool video: Behind the scenes of Medical Device HQ course development
Medical Device HQ
Carpool video: Behind the scenes of Medical Device HQ course development
5:18
The meaning of ’done’ and ‘ready’ in Agile development practices
Medical Device HQ
The meaning of ’done’ and ‘ready’ in Agile development practices
7:40
How to establish a validated state in Agile software development
Medical Device HQ
How to establish a validated state in Agile software development
9:11
Aligning stakeholders in software for medical device development
Medical Device HQ
Aligning stakeholders in software for medical device development
11:22
What’s the difference between ISO 14971 risk management and FMEA?
Medical Device HQ
What’s the difference between ISO 14971 risk management and FMEA?
1:21
Can software itself be a hazard?
Medical Device HQ
Can software itself be a hazard?
0:46
Does safety equal zero risk?
Medical Device HQ
Does safety equal zero risk?
0:54
Who needs risk management for medical devices and ISO 14971 training?
Medical Device HQ
Who needs risk management for medical devices and ISO 14971 training?
1:03
What is essential performance?
Medical Device HQ
What is essential performance?
1:20
What is a remote audit?
Medical Device HQ
What is a remote audit?
0:50
What is a quality management system (QMS) for medical devices?
Medical Device HQ
What is a quality management system (QMS) for medical devices?
1:05
Revalidation requirements in medical device process validation
Medical Device HQ
Revalidation requirements in medical device process validation
9:09
Terminology and explanations in process validation documentation
Medical Device HQ
Terminology and explanations in process validation documentation
6:48
Why and when is process validation for medical devices required?
Medical Device HQ
Why and when is process validation for medical devices required?
5:43
Process validation requirements for medical devices in the US and EU
Medical Device HQ
Process validation requirements for medical devices in the US and EU
13:55
Process validation for medical devices: Guidance from development to market
Medical Device HQ
Process validation for medical devices: Guidance from development to market
6:33
Internal audit process: Key steps and ISO 13485 terminology
Medical Device HQ
Internal audit process: Key steps and ISO 13485 terminology
10:32
Audit findings: Writing nonconformities to ISO 13485
Medical Device HQ
Audit findings: Writing nonconformities to ISO 13485
8:42
Why IEC 60601-1-2 alone isn’t enough for electromagnetic compatibility compliance
Medical Device HQ
Why IEC 60601-1-2 alone isn’t enough for electromagnetic compatibility compliance
6:00
Short course on Agile Medical Device Software Development
Medical Device HQ
Short course on Agile Medical Device Software Development
18:29
Certified internal auditor: Gain certification and build competence
Medical Device HQ
Certified internal auditor: Gain certification and build competence
9:44
Pros and cons of using an internal audit checklist
Medical Device HQ
Pros and cons of using an internal audit checklist
4:51
Why does everyone fail on 60601 testing?
Medical Device HQ
Why does everyone fail on 60601 testing?
3:12
What is happening with the 4th edition of 60601-1?
Medical Device HQ
What is happening with the 4th edition of 60601-1?
6:04
Is read and understood acceptable as training in the medical device industry?
Medical Device HQ
Is read and understood acceptable as training in the medical device industry?
5:17
Process Validation for Medical Devices - Short Course
Medical Device HQ
Process Validation for Medical Devices - Short Course
12:49
Why do medical device product development projects finish late?
Medical Device HQ
Why do medical device product development projects finish late?
6:42
Video testimonial from Yakir Yaniv, ED&U
Medical Device HQ
Video testimonial from Yakir Yaniv, ED&U
1:34
SaMD (Software as Medical Device) 101: 3 types of validations
Medical Device HQ
SaMD (Software as Medical Device) 101: 3 types of validations
2:17
A quick start on the EU MDR – A short practical guide
Medical Device HQ
A quick start on the EU MDR – A short practical guide
2:13
FMEA vs ISO 14971
Medical Device HQ
FMEA vs ISO 14971
10:28
Managing and documenting SOUP and OTS in medical device software
Medical Device HQ
Managing and documenting SOUP and OTS in medical device software
10:44
Video testimonial from Angenette Nordqvist, Somalogic
Medical Device HQ
Video testimonial from Angenette Nordqvist, Somalogic
3:43
Introduction to different classifications rules for medical device software
Medical Device HQ
Introduction to different classifications rules for medical device software
12:24
Short course on PRRC - Person responsible for regulatory compliance
Medical Device HQ
Short course on PRRC - Person responsible for regulatory compliance
12:41
How much does a clinical investigation cost?
Medical Device HQ
How much does a clinical investigation cost?
6:09
The responsibilities of a clinical investigation sponsor
Medical Device HQ
The responsibilities of a clinical investigation sponsor
4:00
How to create a medical device work breakdown structure
Medical Device HQ
How to create a medical device work breakdown structure
14:17
Clinical research for your medical devices
Medical Device HQ
Clinical research for your medical devices
3:47
How to do a clinical investigation in less than 12 months
Medical Device HQ
How to do a clinical investigation in less than 12 months
4:06
Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1
Medical Device HQ
Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1
28:40
The value of the ISO 14155 standard for clinical investigations
Medical Device HQ
The value of the ISO 14155 standard for clinical investigations
3:54
Project management in the medical device industry
Medical Device HQ
Project management in the medical device industry
10:18
Post-market surveillance as a medical device requirement in the EU
Medical Device HQ
Post-market surveillance as a medical device requirement in the EU
21:41
Bloopers: Recording Introduction to the Medical Device Regulation (EU) 2017/745
Medical Device HQ
Bloopers: Recording Introduction to the Medical Device Regulation (EU) 2017/745
0:39
Bloopers: Recording Introduction to Usability Engineering and IEC 62366-1
Medical Device HQ
Bloopers: Recording Introduction to Usability Engineering and IEC 62366-1
0:32
Bloopers: Recording Introduction to Clinical Investigation for Medical Devices and ISO 14155
Medical Device HQ
Bloopers: Recording Introduction to Clinical Investigation for Medical Devices and ISO 14155
0:41
What is not mentioned in IEC 62366-1
Medical Device HQ
What is not mentioned in IEC 62366-1
8:33
Short course on Usability Engineering for Medical Devices and IEC 62366-1
Medical Device HQ
Short course on Usability Engineering for Medical Devices and IEC 62366-1
15:31
The EUDAMED database and EUDAMED logins
Medical Device HQ
The EUDAMED database and EUDAMED logins
11:40
Conformity assessment procedures for medical device manufacturers
Medical Device HQ
Conformity assessment procedures for medical device manufacturers
11:47
What is good clinical practice (GCP)?
Medical Device HQ
What is good clinical practice (GCP)?
6:39
What are the major changes in ISO 14155 2020?
Medical Device HQ
What are the major changes in ISO 14155 2020?
6:44
Authorised representatives, importers and distributors under the MDR
Medical Device HQ
Authorised representatives, importers and distributors under the MDR
7:35
UDI requirements for medical device manufacturers in the EU
Medical Device HQ
UDI requirements for medical device manufacturers in the EU
12:36
Short course on Clinical Investigation for Medical Devices and ISO 14155
Medical Device HQ
Short course on Clinical Investigation for Medical Devices and ISO 14155
19:26
Clinical Investigation and Clinical Evaluation of Medical Devices
Medical Device HQ
Clinical Investigation and Clinical Evaluation of Medical Devices
8:27
What is new in the IEC 62366-1 AMD1:2020?
Medical Device HQ
What is new in the IEC 62366-1 AMD1:2020?
9:48
The usability engineering process and key terms
Medical Device HQ
The usability engineering process and key terms
11:22
Usability engineering and risk management for medical devices
Medical Device HQ
Usability engineering and risk management for medical devices
5:44
Medical Device Regulation codes
Medical Device HQ
Medical Device Regulation codes
17:40
What is a medical device according to the MDR
Medical Device HQ
What is a medical device according to the MDR
14:23
Short course on the Medical Device Regulation (EU) 2017/745
Medical Device HQ
Short course on the Medical Device Regulation (EU) 2017/745
14:55
How to work with medical device risk management
Medical Device HQ
How to work with medical device risk management
7:27
Documentation for a medical device product development process (Part 1)
Medical Device HQ
Documentation for a medical device product development process (Part 1)
11:26
How to perform the summative evaluation for medical devices (IEC 62366-1)
Medical Device HQ
How to perform the summative evaluation for medical devices (IEC 62366-1)
18:35
What is a medical device?
Medical Device HQ
What is a medical device?
5:46
System, item and units in medical device software
Medical Device HQ
System, item and units in medical device software
9:31
Documenting compliance with IEC 62304 in medical device software development
Medical Device HQ
Documenting compliance with IEC 62304 in medical device software development
12:34
Risk control measures in medical device software
Medical Device HQ
Risk control measures in medical device software
14:56
Medical device software risk management and IEC 62304 terminology
Medical Device HQ
Medical device software risk management and IEC 62304 terminology
12:25
Medical device design control terminology
Medical Device HQ
Medical device design control terminology
10:49
Project risk management for medical devices: What’s to know?
Medical Device HQ
Project risk management for medical devices: What’s to know?
7:42
Identify IEC 60601-1 standard insulation requirements for electrical medical devices
Medical Device HQ
Identify IEC 60601-1 standard insulation requirements for electrical medical devices
6:35
General safety requirements for electrical medical devices
Medical Device HQ
General safety requirements for electrical medical devices
8:35
How to define IEC 60601 test plans and protocols for medical devices
Medical Device HQ
How to define IEC 60601 test plans and protocols for medical devices
7:06
How to identify and manage critical components
Medical Device HQ
How to identify and manage critical components
10:03
Design control for medical devices - what is it and why you should do it
Medical Device HQ
Design control for medical devices - what is it and why you should do it
7:01
Developing an insulation diagram for electrical medical devices
Medical Device HQ
Developing an insulation diagram for electrical medical devices
7:07
Safety for Electrical Medical Devices - Short course
Medical Device HQ
Safety for Electrical Medical Devices - Short course
12:44
How to integrate proactive safety by design with medical device risk management
Medical Device HQ
How to integrate proactive safety by design with medical device risk management
7:40
Online and live virtual courses with Medical Device HQ
Medical Device HQ
Online and live virtual courses with Medical Device HQ
8:51
Medical Device Software Development Short Course
Medical Device HQ
Medical Device Software Development Short Course
23:06
How to do a medical device design review
Medical Device HQ
How to do a medical device design review
11:33
What is new in ISO 14971 2019
Medical Device HQ
What is new in ISO 14971 2019
16:03
Risk management for medical devices and ISO 14971 - Online introductory course
Medical Device HQ
Risk management for medical devices and ISO 14971 - Online introductory course
17:07
How to estimate risk for a medical device according to ISO 14971:2019
Medical Device HQ
How to estimate risk for a medical device according to ISO 14971:2019
15:22
Design Control for Medical Devices - Online introductory course
Medical Device HQ
Design Control for Medical Devices - Online introductory course
17:31