Videos
Walkthroughs and explainers for medical device compliance — pricing, audit prep, technical documentation, and more.
11:05
eQMS MCP Server: Talk to Your QMS! (OpenRegulatory Formwork)
Dr. Oliver Eidel
7:50
AI-Generate Your QMS + Technical Documentation in 3 Minutes
Dr. Oliver Eidel
43:32
Free ISO 19011 Internal Auditor Training (for Medical Devices)
Dr. Oliver Eidel
12:04
Free MDR PRRC Course (Person Responsible for Regulatory Compliance)
Dr. Oliver Eidel
9:40
Medizinprodukteberater Course: Examples
Dr. Oliver Eidel
10:40
Medizinprodukteberater Course: Requirements, Tasks, Responsibilities
Dr. Oliver Eidel
6:23
Post-Market Surveillance: The Periodic Safety Update Report (PSUR)
Dr. Oliver Eidel
12:34
Medical Device Post-Market Surveillance: The Plan
Dr. Oliver Eidel
5:16
Medical Device Post-Market Surveillance: The Process
Dr. Oliver Eidel
6:15
Free Medical Device Post-Market Surveillance Course: Concepts
Dr. Oliver Eidel
7:52
Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)
Dr. Oliver Eidel
9:28
Post-Market Clinical Follow-up: Concepts and Plan
Dr. Oliver Eidel
6:19
Clinical Evaluation: Post-Market Surveillance (PMS) Database Search
Dr. Oliver Eidel
11:52
Literature Search For Clinical Evaluation of Medical Devices
Dr. Oliver Eidel
12:37
Clinical Evaluation: The Clinical Evaluation Report (CER)
Dr. Oliver Eidel
6:24
Clinical Evaluation: Understanding the Phases and the Plan
Dr. Oliver Eidel
5:18
Free Clinical Evaluation Course, Part 1: Understanding the Process
Dr. Oliver Eidel
15:16
Registering Your UDI in EUDAMED (Medical Device Database)
Dr. Oliver Eidel
5:00
Creating a UDI-PI and Data Matrix Code at IFA
Dr. Oliver Eidel
2:29
Generating the Basic UDI-DI at IFA
Dr. Oliver Eidel
5:24
Hack: UDI-DI for Free with HPC at IFA (for Medical Devices)
Dr. Oliver Eidel
7:10
IFA: Ordering a PPN via Auftragstabelle B3
Dr. Oliver Eidel
9:05
Registering As a Customer at IFA to Create a UDI
Dr. Oliver Eidel
7:22
Creating a Medical Device UDI at IFA (Unique Device Identifier)
Dr. Oliver Eidel
10:36
UDI-PI and Barcode With Application Identifiers in GS1
Dr. Oliver Eidel
3:13
Creating the Basic UDI-DI as GMN in GS1
Dr. Oliver Eidel
10:15
How to Use The GS1 GTIN Manager (UDIs for Medical Devices)
Dr. Oliver Eidel
11:00
Registering a UDI with GS1 (Unique Device Identifiers for Medical Devices)
Dr. Oliver Eidel
11:59
Free Course: Understanding Unique Device Identifiers (UDIs) For Medical Devices
Dr. Oliver Eidel
6:55
Software Validation (ISO 13485 QMS), Part 2
Dr. Oliver Eidel
8:06
Software Validation (as part of your QMS, for the ISO 13485)
Dr. Oliver Eidel
6:07
Purchasing: Supplier Checklist For ISO 13485 Compliance
Dr. Oliver Eidel
10:39
Purchasing SOP For Medical Devices (ISO 13485)
Dr. Oliver Eidel
16:05
Human Resources Administration For Medical Device Companies (ISO 13485)
Dr. Oliver Eidel
12:18
Vigilance For EU MDR and ISO 13485 Compliance
Dr. Oliver Eidel
13:11
CAPAs (Corrective and Preventive Actions) For ISO 13485 Compliance
Dr. Oliver Eidel
14:05
EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)
Dr. Oliver Eidel
9:27
EU MDR Post-Market Surveillance, Part 1 (+ ISO 13485)
Sven Piechottka
8:45
Feedback Management For Medical Device (ISO 13485) Compliance
Sven Piechottka
6:35
Internal Audits (ISO 13485 Compliance)
Sven Piechottka
7:09
Management Reviews For ISO 13485 Compliance (Medical Devices)
Sven Piechottka
15:24
Certification and Product Registration Process
Sven Piechottka
10:46
Document and Record Control For The ISO 13485
Sven Piechottka
10:17
Free Course: Quality Management For Medical Devices (ISO 13485 QMS)
Sven Piechottka
10:47
Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366)
Dr. Oliver Eidel
7:03
Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices)
Dr. Oliver Eidel
13:07
Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366)
Dr. Oliver Eidel
12:24
Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366)
Dr. Oliver Eidel
10:59
Free Usability Engineering Course (Medical Devices - IEC 62366)
Dr. Oliver Eidel
10:48
ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report
Dr. Oliver Eidel
11:24
No One Does Preliminary Hazards Analysis (Mostly) (ISO 14971 Medical Device Risk Analysis)
Dr. Oliver Eidel
15:38
Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)
Dr. Oliver Eidel
14:40
Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)
Dr. Oliver Eidel
16:13
Risk Controls Make Your Life Easier (Medical Device Risk Management)
Dr. Oliver Eidel
7:44
Medical Device Failure Modes (ISO 14971 Risk Analysis)
Dr. Oliver Eidel
15:51
Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971)
Dr. Oliver Eidel
16:50
Medical Device Risk Analysis: Risk Matrix (ISO 14971)
Dr. Oliver Eidel
12:05
Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971)
Dr. Oliver Eidel
6:34
AI QMS: Where ChatGPT Fails (Cybersecurity Requirements)
Dr. Oliver Eidel
8:06
ChatGPT QMS For Editing Documents (Fix Audit Findings)
Dr. Oliver Eidel
13:09
Risk Management With AI: 1,000x faster! (in seconds)
Dr. Oliver Eidel
7:02
AI-Powered eQMS: 100x Faster Trainings!
Dr. Oliver Eidel
17:26
Jira / GitHub Integration, Machine Learning Docs, Known Anomalies (Finishing IEC 62304 Compliance)
Dr. Oliver Eidel
16:56
Change Management For Software as a Medical Device (IEC 62034 Compliance)
Dr. Oliver Eidel
21:51
Software Release and Review: Final Tasks For IEC 62304 Compliance For Software as Medical Device
Dr. Oliver Eidel
10:09
Software Architecture For Medical Device Software (IEC 62304 Compliance)
Dr. Oliver Eidel
13:54
IEC 62304 - Compliant Software Development Process (SOP Software Development)
Dr. Oliver Eidel
10:10
Writing a Software Development and Maintenance Plan For IEC 62304 Compliance
Dr. Oliver Eidel
15:54
Documenting SOUP (Software of Unknown Provenance) For IEC 62304 and Medical Device Compliance
Dr. Oliver Eidel
24:36
Software Test Documentation For IEC 62304 Compliance (Medical Device Software)
Dr. Oliver Eidel
21:37
Writing Software Requirements For IEC 62304 Compliance
Dr. Oliver Eidel
9:19
Understanding the IEC 62304 Safety Classes and the Mysterious V-Model
Dr. Oliver Eidel
8:44
Actually Getting The Standard (IEC 62304 Course Episode 2)
Dr. Oliver Eidel
5:15
Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD)
Dr. Oliver Eidel
4:43
Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates
Dr. Oliver Eidel
5:03
QMS Automation With The Formwork QMS Overview
Dr. Oliver Eidel
49:28
B2B Sales And Generating Revenue: Tatyana Eliseeva, Healthcare Startup Meetup #3
Dr. Oliver Eidel
10:17
Medical Device QMS Software Comparison: Shady Business Practices!
Dr. Oliver Eidel
6:37
Agile Development For Medical Device Software: Is It Possible?
Dr. Oliver Eidel
3:40
Get Notified About Regulatory Updates
Dr. Oliver Eidel
9:21
Jira QMS: Can You Set Up a QMS And Requirements Management In Jira For Medical Device Compliance?
Dr. Oliver Eidel
5:37
Get The ISO 13485 Almost For Free: How to Buy Standards on the Estonian Website
Dr. Oliver Eidel
2:18
Bringing Transparency To MDR Compliance
Dr. Oliver Eidel
3:06
Free MDR Templates
Dr. Oliver Eidel
8:09
ChatGPT For Medical Device Documentation (MDR / FDA)?
Dr. Oliver Eidel
5:24
Software Detailed Design Documentation in Formwork
Dr. Oliver Eidel
47:35
Matthew Fenech: DiGA For Glucose Control at Una Health (Healthcare Startup Meetup #2)
Dr. Oliver Eidel
5:18
MDR Clinical Evaluation: Understanding the Process
Dr. Oliver Eidel
6:33
QMS Overview: Automate Your ISO 13485 Documents and Records
Dr. Oliver Eidel
24:46
Leander Märkisch: Building AI For Radiology at Floy (Healthcare Startup Meetup #1)
Dr. Oliver Eidel
7:04
Use ChatGPT to Generate Your QMS In Minutes
Dr. Oliver Eidel
4:55
Custom File Documents / Records
Dr. Oliver Eidel
8:59
QMS Trainings: Automatically Train Your Employees in Formwork
Dr. Oliver Eidel
7:06
Formwork Batch Export: The Only eQMS Software Without Lock-In
Dr. Oliver Eidel
7:17
Manage your Technical Documentation in Formwork (eQMS software)
Dr. Oliver Eidel
12:06
ChatGPT For Medical Devices And Automating QMS Trainings
Dr. Oliver Eidel
12:48
Auto-Generate Audit Spreadsheets For Requirements Management
Dr. Oliver Eidel
7:25
Save Time By Copying OpenRegulatory Templates
Dr. Oliver Eidel
15:20
How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants
Dr. Oliver Eidel
14:35
What Do You Need To Do? Looking At IEC 62304 And Other Docs
Dr. Oliver Eidel
10:12
Medical Device Compliance: Cost & Duration
Dr. Oliver Eidel
7:22
Getting a MDR UDI From IFA
Sören Hornof
9:57
Getting a MDR UDI from GS1
Sören Hornof
10:16
Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance)
Dr. Oliver Eidel
5:42
Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)
Dr. Oliver Eidel
7:34
How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?
Dr. Oliver Eidel
7:07
Medical Device Software Development: Introduction To The IEC 62304
Dr. Oliver Eidel
11:59
Introduction To MDR UDIs
Sören Hornof
5:41
Hardware Medical Devices in Formwork
Dr. Oliver Eidel
10:45
Formwork vs GitHub, Jira, ClickUp, Asana
Dr. Oliver Eidel
7:56
AI-Assisted Writing of Technical Documentation
Dr. Oliver Eidel
10:36
Manage Your Medical Device CAPAs in Formwork (eQMS)
Dr. Oliver Eidel
9:25
Formwork: Auto-Generate Your Technical Documentation With The New Audit Export
Dr. Oliver Eidel
10:46
Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)
Dr. Oliver Eidel
6:35
Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance)
Dr. Oliver Eidel
11:39
Writing a Quality Manual For Medical Device Quality Management (ISO 13485)
Dr. Oliver Eidel
9:06
The Magical Wizard and How It Helps You
Dr. Oliver Eidel
26:01
SaMD Meetup #11: Post-Market Surveillance
Dr. Oliver Eidel
13:07
Automate Your Medical Device Risk Management With Formwork, An eQMS (ISO 14971 Compliance)
Dr. Oliver Eidel
6:04
Audit Export and Sanity Check
Dr. Oliver Eidel