Все публикации

0:04:51

Pros and cons of using an internal audit checklist

0:03:12

Why does everyone fail on 60601 testing?

0:06:03

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

0:05:17

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

0:12:49

Process Validation for Medical Devices - Short Course

0:06:42

Why do medical device product development projects finish late?

0:01:34

Video testimonial from Yakir Yaniv, ED&U

0:02:17

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

0:02:13

A quick start on the EU MDR – A short practical guide

0:10:28

FMEA vs ISO 14971

0:10:44

Managing and documenting SOUP and OTS in medical device software

0:12:24

Introduction to different classifications rules for medical device software

0:12:41

Short course on PRRC - Person responsible for regulatory compliance

0:06:09

How much does a clinical investigation cost?

0:04:00

The responsibilities of a clinical investigation sponsor

0:14:17

How to create a medical device work breakdown structure

0:03:47

Clinical research for your medical devices

0:04:06

How to do a clinical investigation in less than 12 months

0:28:40

Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1

0:03:54

The value of the ISO 14155 standard for clinical investigations

0:10:18

Project management in the medical device industry

0:21:41

Post-market surveillance as a medical device requirement in the EU

0:00:41

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

0:00:32

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