Medical Device HQ
@MedicalDeviceHQ - 76 本の動画
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6:48
Terminology and explanations in process validation documentation
5:43
Why and when is process validation for medical devices required?
13:55
Process validation requirements for medical devices in the US and EU
6:33
Process validation for medical devices: Guidance from development to market
10:32
Internal audit process: Key steps and ISO 13485 terminology
8:42
Audit findings: Writing nonconformities to ISO 13485
6:00
Why IEC 60601-1-2 alone isn’t enough for electromagnetic compatibility compliance
18:29
Short course on Agile Medical Device Software Development
9:44
Certified internal auditor: Gain certification and build competence
4:51
Pros and cons of using an internal audit checklist
3:12
Why does everyone fail on 60601 testing?
6:04
What is happening with the 4th edition of 60601-1?
5:17
Is read and understood acceptable as training in the medical device industry?
12:49
Process Validation for Medical Devices - Short Course
6:42
Why do medical device product development projects finish late?
1:34
Video testimonial from Yakir Yaniv, ED&U
2:17
SaMD (Software as Medical Device) 101: 3 types of validations
2:13
A quick start on the EU MDR – A short practical guide
10:28
FMEA vs ISO 14971
10:44
Managing and documenting SOUP and OTS in medical device software
3:43
Video testimonial from Angenette Nordqvist, Somalogic
12:24
Introduction to different classifications rules for medical device software
12:41
Short course on PRRC - Person responsible for regulatory compliance
6:09
How much does a clinical investigation cost?
4:00
The responsibilities of a clinical investigation sponsor
14:17
How to create a medical device work breakdown structure
3:47
Clinical research for your medical devices
4:06
How to do a clinical investigation in less than 12 months
28:40
Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1
3:54
The value of the ISO 14155 standard for clinical investigations
10:18
Project management in the medical device industry
21:41
Post-market surveillance as a medical device requirement in the EU
0:39
Bloopers: Recording Introduction to the Medical Device Regulation (EU) 2017/745
0:32
Bloopers: Recording Introduction to Usability Engineering and IEC 62366-1
0:41
Bloopers: Recording Introduction to Clinical Investigation for Medical Devices and ISO 14155
8:33
What is not mentioned in IEC 62366-1
15:31
Short course on Usability Engineering for Medical Devices and IEC 62366-1
11:40
The EUDAMED database and EUDAMED logins
11:47
Conformity assessment procedures for medical device manufacturers
6:39
What is good clinical practice (GCP)?
6:44
What are the major changes in ISO 14155 2020?
7:35
Authorised representatives, importers and distributors under the MDR
12:36
UDI requirements for medical device manufacturers in the EU
19:26
Short course on Clinical Investigation for Medical Devices and ISO 14155
8:27
Clinical Investigation and Clinical Evaluation of Medical Devices
9:48
What is new in the IEC 62366-1 AMD1:2020?
11:22
The usability engineering process and key terms
5:44
Usability engineering and risk management for medical devices
17:40
Medical Device Regulation codes
14:23
What is a medical device according to the MDR
14:55
Short course on the Medical Device Regulation (EU) 2017/745
7:27
How to work with medical device risk management
11:26
Documentation for a medical device product development process (Part 1)
18:35
How to perform the summative evaluation for medical devices (IEC 62366-1)
5:46
What is a medical device?
9:31
System, item and units in medical device software
12:34
Documenting compliance with IEC 62304 in medical device software development
14:56
Risk control measures in medical device software
12:25
Medical device software risk management and IEC 62304 terminology
10:49
Medical device design control terminology
7:42
Project risk management for medical devices: What’s to know?
6:35
Identify IEC 60601-1 standard insulation requirements for electrical medical devices
8:35
General safety requirements for electrical medical devices
7:06
How to define IEC 60601 test plans and protocols for medical devices
10:03
How to identify and manage critical components
7:01
Design control for medical devices - what is it and why you should do it
7:07
Developing an insulation diagram for electrical medical devices
12:44
Safety for Electrical Medical Devices - Short course
7:40
How to integrate proactive safety by design with medical device risk management
8:51
Online and live virtual courses with Medical Device HQ
23:06
Medical Device Software Development Short Course
11:33
How to do a medical device design review
16:03
What is new in ISO 14971 2019
17:07
Risk management for medical devices and ISO 14971 - Online introductory course
15:22
How to estimate risk for a medical device according to ISO 14971:2019
17:31
Design Control for Medical Devices - Online introductory course