IEC 62304: Medical Device Software Development

11:05

eQMS MCP Server: Talk to Your QMS! (OpenRegulatory Formwork)

Dr. Oliver Eidel

238 views · 3 months ago

7:50

AI-Generate Your QMS + Technical Documentation in 3 Minutes

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472 views · 6 months ago

43:32

Free ISO 19011 Internal Auditor Training (for Medical Devices)

Dr. Oliver Eidel

60 views · 7 months ago

12:04

Free MDR PRRC Course (Person Responsible for Regulatory Compliance)

Dr. Oliver Eidel

55 views · 7 months ago

9:40

Medizinprodukteberater Course: Examples

Dr. Oliver Eidel

29 views · 7 months ago

10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago

6:23

Post-Market Surveillance: The Periodic Safety Update Report (PSUR)

Dr. Oliver Eidel

30 views · 7 months ago

12:34

Medical Device Post-Market Surveillance: The Plan

Dr. Oliver Eidel

24 views · 7 months ago

5:16

Medical Device Post-Market Surveillance: The Process

Dr. Oliver Eidel

25 views · 7 months ago

6:15

Free Medical Device Post-Market Surveillance Course: Concepts

Dr. Oliver Eidel

29 views · 7 months ago

7:52

Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)

Dr. Oliver Eidel

14 views · 7 months ago

9:28

Post-Market Clinical Follow-up: Concepts and Plan

Dr. Oliver Eidel

23 views · 7 months ago

6:19

Clinical Evaluation: Post-Market Surveillance (PMS) Database Search

Dr. Oliver Eidel

32 views · 7 months ago

11:52

Literature Search For Clinical Evaluation of Medical Devices

Dr. Oliver Eidel

73 views · 7 months ago

12:37

Clinical Evaluation: The Clinical Evaluation Report (CER)

Dr. Oliver Eidel

59 views · 7 months ago

6:24

Clinical Evaluation: Understanding the Phases and the Plan

Dr. Oliver Eidel

46 views · 7 months ago

5:18

Free Clinical Evaluation Course, Part 1: Understanding the Process

Dr. Oliver Eidel

81 views · 8 months ago

15:16

Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 8 months ago

5:00

Creating a UDI-PI and Data Matrix Code at IFA

Dr. Oliver Eidel

46 views · 8 months ago

2:29

Generating the Basic UDI-DI at IFA

Dr. Oliver Eidel

23 views · 8 months ago

5:24

Hack: UDI-DI for Free with HPC at IFA (for Medical Devices)

Dr. Oliver Eidel

10 views · 8 months ago

7:10

IFA: Ordering a PPN via Auftragstabelle B3

Dr. Oliver Eidel

9 views · 8 months ago

9:05

Registering As a Customer at IFA to Create a UDI

Dr. Oliver Eidel

12 views · 8 months ago

7:22

Creating a Medical Device UDI at IFA (Unique Device Identifier)

Dr. Oliver Eidel

21 views · 8 months ago

10:36

UDI-PI and Barcode With Application Identifiers in GS1

Dr. Oliver Eidel

84 views · 8 months ago

3:13

Creating the Basic UDI-DI as GMN in GS1

Dr. Oliver Eidel

173 views · 8 months ago

10:15

How to Use The GS1 GTIN Manager (UDIs for Medical Devices)

Dr. Oliver Eidel

42 views · 8 months ago

11:00

Registering a UDI with GS1 (Unique Device Identifiers for Medical Devices)

Dr. Oliver Eidel

31 views · 8 months ago

11:59

Free Course: Understanding Unique Device Identifiers (UDIs) For Medical Devices

Dr. Oliver Eidel

85 views · 8 months ago

6:55

Software Validation (ISO 13485 QMS), Part 2

Dr. Oliver Eidel

103 views · 8 months ago

8:06

Software Validation (as part of your QMS, for the ISO 13485)

Dr. Oliver Eidel

106 views · 8 months ago

6:07

Purchasing: Supplier Checklist For ISO 13485 Compliance

Dr. Oliver Eidel

23 views · 8 months ago

10:39

Purchasing SOP For Medical Devices (ISO 13485)

Dr. Oliver Eidel

41 views · 8 months ago

16:05

Human Resources Administration For Medical Device Companies (ISO 13485)

Dr. Oliver Eidel

21 views · 8 months ago

12:18

Vigilance For EU MDR and ISO 13485 Compliance

Dr. Oliver Eidel

16 views · 8 months ago

13:11

CAPAs (Corrective and Preventive Actions) For ISO 13485 Compliance

Dr. Oliver Eidel

36 views · 8 months ago

14:05

EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)

Dr. Oliver Eidel

19 views · 8 months ago

5:15

Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD)

Dr. Oliver Eidel

1.4 K views · over 1 year ago

8:44

Actually Getting The Standard (IEC 62304 Course Episode 2)

Dr. Oliver Eidel

591 views · over 1 year ago

9:19

Understanding the IEC 62304 Safety Classes and the Mysterious V-Model

Dr. Oliver Eidel

742 views · over 1 year ago

21:37

Writing Software Requirements For IEC 62304 Compliance

Dr. Oliver Eidel

929 views · over 1 year ago

24:36

Software Test Documentation For IEC 62304 Compliance (Medical Device Software)

Dr. Oliver Eidel

626 views · over 1 year ago

15:54

Documenting SOUP (Software of Unknown Provenance) For IEC 62304 and Medical Device Compliance

Dr. Oliver Eidel

431 views · over 1 year ago

10:10

Writing a Software Development and Maintenance Plan For IEC 62304 Compliance

Dr. Oliver Eidel

250 views · over 1 year ago

13:54

IEC 62304 - Compliant Software Development Process (SOP Software Development)

Dr. Oliver Eidel

328 views · over 1 year ago

10:09

Software Architecture For Medical Device Software (IEC 62304 Compliance)

Dr. Oliver Eidel

376 views · over 1 year ago

21:51

Software Release and Review: Final Tasks For IEC 62304 Compliance For Software as Medical Device

Dr. Oliver Eidel

217 views · over 1 year ago

16:56

Change Management For Software as a Medical Device (IEC 62034 Compliance)

Dr. Oliver Eidel

297 views · over 1 year ago

17:26

Jira / GitHub Integration, Machine Learning Docs, Known Anomalies (Finishing IEC 62304 Compliance)

Dr. Oliver Eidel

205 views · over 1 year ago