09:44

Certified internal auditor: Gain certification and build competence

04:24

How do you integrate an off the shelf power supply while meeting IEC 60601-1 requirements?

06:00

Rechargeable batteries in medical devices – Challenges and pitfalls

04:51

Pros and cons of using an internal audit checklist

03:12

Why does everyone fail on 60601 testing?

06:03

What is happening with the 4th edition of 60601-1?

05:17

Is read and understood acceptable as training in the medical device industry?

12:49

Process Validation for Medical Devices - Short Course

06:42

Why do medical device product development projects finish late?

01:34

Video testimonial from Yakir Yaniv, ED&U

02:17

SaMD (Software as Medical Device) 101: 3 types of validations

02:13

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

03:43

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

06:09

How much does a clinical investigation cost?

04:00

The responsibilities of a clinical investigation sponsor

14:17

How to create a medical device work breakdown structure

03:47

Clinical research for your medical devices

04:06

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

03:54

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

00:39

Bloopers: Recording Introduction to the Medical Device Regulation (EU) 2017/745

00:32

Bloopers: Recording Introduction to Usability Engineering and IEC 62366-1

00:41

Bloopers: Recording Introduction to Clinical Investigation for Medical Devices and ISO 14155

08:33

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

06:39

What is good clinical practice (GCP)?

06:44

What are the major changes in ISO 14155 2020?

07:35

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

08:27

Clinical Investigation and Clinical Evaluation of Medical Devices

09:48

What is new in the IEC 62366-1 AMD1:2020?

11:22

The usability engineering process and key terms

05:44

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

07:27

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)

05:46

What is a medical device?

09:31

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

07:42

Project risk management for medical devices: What’s to know?

06:35

Identify IEC 60601-1 standard insulation requirements for electrical medical devices

08:35

General safety requirements for electrical medical devices

07:06

How to define IEC 60601 test plans and protocols for medical devices

10:03

How to identify and manage critical components

07:01

Design control for medical devices - what is it and why you should do it