Videos

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

Dr. Oliver Eidel

472 views · 6 months ago

43:32

Free ISO 19011 Internal Auditor Training (for Medical Devices)

Dr. Oliver Eidel

60 views · 6 months ago

12:04

Free MDR PRRC Course (Person Responsible for Regulatory Compliance)

Dr. Oliver Eidel

55 views · 6 months ago

9:40

Medizinprodukteberater Course: Examples

Dr. Oliver Eidel

29 views · 6 months ago

10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 6 months ago

6:23

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

Dr. Oliver Eidel

30 views · 6 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 · 7 months ago

15:16

Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 7 months ago

5:00

Creating a UDI-PI and Data Matrix Code at IFA

Dr. Oliver Eidel

46 views · 7 months ago

2:29

Generating the Basic UDI-DI at IFA

Dr. Oliver Eidel

23 views · 7 months ago

5:24

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

Dr. Oliver Eidel

10 views · 7 months ago

7:10

IFA: Ordering a PPN via Auftragstabelle B3

Dr. Oliver Eidel

9 views · 7 months ago

9:05

Registering As a Customer at IFA to Create a UDI

Dr. Oliver Eidel

12 views · 7 months ago

7:22

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

Dr. Oliver Eidel

21 views · 7 months ago

10:36

UDI-PI and Barcode With Application Identifiers in GS1

Dr. Oliver Eidel

84 views · 7 months ago

3:13

Creating the Basic UDI-DI as GMN in GS1

Dr. Oliver Eidel

173 views · 7 months ago

10:15

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

Dr. Oliver Eidel

42 views · 7 months ago

11:00

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

Dr. Oliver Eidel

31 views · 7 months ago

11:59

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

Dr. Oliver Eidel

85 views · 7 months ago

6:55

Software Validation (ISO 13485 QMS), Part 2

Dr. Oliver Eidel

103 views · 7 months ago

8:06

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

Dr. Oliver Eidel

106 views · 7 months ago

6:07

Purchasing: Supplier Checklist For ISO 13485 Compliance

Dr. Oliver Eidel

23 views · 7 months ago

10:39

Purchasing SOP For Medical Devices (ISO 13485)

Dr. Oliver Eidel

41 views · 7 months ago

16:05

Human Resources Administration For Medical Device Companies (ISO 13485)

Dr. Oliver Eidel

21 views · 7 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

9:27

EU MDR Post-Market Surveillance, Part 1 (+ ISO 13485)

Sven Piechottka

4 views · 8 months ago

8:45

Feedback Management For Medical Device (ISO 13485) Compliance

Sven Piechottka

7 views · 8 months ago

6:35

Internal Audits (ISO 13485 Compliance)

Sven Piechottka

15 views · 8 months ago

7:09

Management Reviews For ISO 13485 Compliance (Medical Devices)

Sven Piechottka

12 views · 8 months ago

15:24

Certification and Product Registration Process

Sven Piechottka

14 views · 8 months ago

10:46

Document and Record Control For The ISO 13485

Sven Piechottka

19 views · 8 months ago

10:17

Free Course: Quality Management For Medical Devices (ISO 13485 QMS)

Sven Piechottka

27 views · 8 months ago

10:47

Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366)

Dr. Oliver Eidel

23 views · 8 months ago

7:03

Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices)

Dr. Oliver Eidel

38 views · 8 months ago

13:07

Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366)

Dr. Oliver Eidel

36 views · 8 months ago

12:24

Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366)

Dr. Oliver Eidel

32 views · 8 months ago

10:59

Free Usability Engineering Course (Medical Devices - IEC 62366)

Dr. Oliver Eidel

77 views · 8 months ago

10:48

ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report

Dr. Oliver Eidel

39 views · 8 months ago

11:24

No One Does Preliminary Hazards Analysis (Mostly) (ISO 14971 Medical Device Risk Analysis)

Dr. Oliver Eidel

43 views · 9 months ago

15:38

Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)

Dr. Oliver Eidel

35 views · 9 months ago

14:40

Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)

Dr. Oliver Eidel

36 views · 9 months ago

16:13

Risk Controls Make Your Life Easier (Medical Device Risk Management)

Dr. Oliver Eidel

33 views · 9 months ago

7:44

Medical Device Failure Modes (ISO 14971 Risk Analysis)

Dr. Oliver Eidel

45 views · 9 months ago

15:51

Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971)

Dr. Oliver Eidel

70 views · 9 months ago

16:50

Medical Device Risk Analysis: Risk Matrix (ISO 14971)

Dr. Oliver Eidel

94 views · 9 months ago

12:05

Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971)

Dr. Oliver Eidel

98 views · 9 months ago

6:34

AI QMS: Where ChatGPT Fails (Cybersecurity Requirements)

Dr. Oliver Eidel

60 views · 12 months ago

8:06

ChatGPT QMS For Editing Documents (Fix Audit Findings)

Dr. Oliver Eidel

101 views · 12 months ago

13:09

Risk Management With AI: 1,000x faster! (in seconds)

Dr. Oliver Eidel

248 views · about 1 year ago

7:02

AI-Powered eQMS: 100x Faster Trainings!

Dr. Oliver Eidel

92 views · about 1 year ago

17:26

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

Dr. Oliver Eidel

205 views · about 1 year ago

16:56

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

Dr. Oliver Eidel

297 views · about 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 · about 1 year ago

10:09

Software Architecture For Medical Device Software (IEC 62304 Compliance)

Dr. Oliver Eidel

376 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

10:10

Writing a Software Development and Maintenance Plan For IEC 62304 Compliance

Dr. Oliver Eidel

250 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

24:36

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

Dr. Oliver Eidel

626 views · over 1 year ago

21:37

Writing Software Requirements For IEC 62304 Compliance

Dr. Oliver Eidel

929 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

8:44

Actually Getting The Standard (IEC 62304 Course Episode 2)

Dr. Oliver Eidel

591 views · over 1 year 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

4:43

Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates

Dr. Oliver Eidel

258 views · almost 2 years ago

5:03

QMS Automation With The Formwork QMS Overview

Dr. Oliver Eidel

260 views · almost 2 years ago

49:28

B2B Sales And Generating Revenue: Tatyana Eliseeva, Healthcare Startup Meetup #3

Dr. Oliver Eidel

79 views · almost 2 years ago

10:17

Medical Device QMS Software Comparison: Shady Business Practices!

Dr. Oliver Eidel

695 views · about 2 years ago

6:37

Agile Development For Medical Device Software: Is It Possible?

Dr. Oliver Eidel

333 views · about 2 years ago

3:40

Get Notified About Regulatory Updates

Dr. Oliver Eidel

108 views · about 2 years ago

9:21

Jira QMS: Can You Set Up a QMS And Requirements Management In Jira For Medical Device Compliance?

Dr. Oliver Eidel

780 views · about 2 years ago

5:37

Get The ISO 13485 Almost For Free: How to Buy Standards on the Estonian Website

Dr. Oliver Eidel

226 views · about 2 years ago

2:18

Bringing Transparency To MDR Compliance

Dr. Oliver Eidel

46 views · about 2 years ago

3:06

Free MDR Templates

Dr. Oliver Eidel

103 views · about 2 years ago

8:09

ChatGPT For Medical Device Documentation (MDR / FDA)?

Dr. Oliver Eidel

785 views · about 2 years ago

5:24

Software Detailed Design Documentation in Formwork

Dr. Oliver Eidel

289 views · over 2 years ago

47:35

Matthew Fenech: DiGA For Glucose Control at Una Health (Healthcare Startup Meetup #2)

Dr. Oliver Eidel

264 views · over 2 years ago

5:18

MDR Clinical Evaluation: Understanding the Process

Dr. Oliver Eidel

167 views · over 2 years ago

6:33

QMS Overview: Automate Your ISO 13485 Documents and Records

Dr. Oliver Eidel

498 views · over 2 years ago

24:46

Leander Märkisch: Building AI For Radiology at Floy (Healthcare Startup Meetup #1)

Dr. Oliver Eidel

218 views · over 2 years ago

7:04

Use ChatGPT to Generate Your QMS In Minutes

Dr. Oliver Eidel

1.7 K views · over 2 years ago

4:55

Custom File Documents / Records

Dr. Oliver Eidel

134 views · almost 3 years ago

8:59

QMS Trainings: Automatically Train Your Employees in Formwork

Dr. Oliver Eidel

109 views · almost 3 years ago

7:06

Formwork Batch Export: The Only eQMS Software Without Lock-In

Dr. Oliver Eidel

64 views · almost 3 years ago

7:17

Manage your Technical Documentation in Formwork (eQMS software)

Dr. Oliver Eidel

185 views · almost 3 years ago

12:06

ChatGPT For Medical Devices And Automating QMS Trainings

Dr. Oliver Eidel

242 views · almost 3 years ago

12:48

Auto-Generate Audit Spreadsheets For Requirements Management

Dr. Oliver Eidel

132 views · almost 3 years ago

7:25

Save Time By Copying OpenRegulatory Templates

Dr. Oliver Eidel

191 views · almost 3 years ago

15:20

How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants

Dr. Oliver Eidel

190 views · almost 3 years ago

14:35

What Do You Need To Do? Looking At IEC 62304 And Other Docs

Dr. Oliver Eidel

345 views · almost 3 years ago