Канал: OpenRegulatory

Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates

Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates

QMS Automation With The Formwork QMS Overview

QMS Automation With The Formwork QMS Overview

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

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

Agile Development For Medical Device Software: Is It Possible?

Agile Development For Medical Device Software: Is It Possible?

Launching Free Regulatory Updates: Stay Updated With The ISO 13485 And Other Standards

Launching Free Regulatory Updates: Stay Updated With The ISO 13485 And Other Standards

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

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

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

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

Bringing Transparency To MDR Compliance

Bringing Transparency To MDR Compliance

Free MDR Templates

Free MDR Templates

ChatGPT For Medical Device Documentation (MDR / FDA)?

ChatGPT For Medical Device Documentation (MDR / FDA)?

Software Detailed Design Documentation in Formwork

Software Detailed Design Documentation in Formwork

Medical Device QMS Software Comparison: Shady Business Practices!

Medical Device QMS Software Comparison: Shady Business Practices!

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

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

MDR Clinical Evaluation: Understanding the Process

MDR Clinical Evaluation: Understanding the Process

QMS Overview: Automate Your ISO 13485 Documents and Records

QMS Overview: Automate Your ISO 13485 Documents and Records

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

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

Use ChatGPT to Generate Your QMS In Minutes

Use ChatGPT to Generate Your QMS In Minutes

Medical Device Starter Course, Part 6: ChatGPT For Medical Devices And Automating QMS Trainings

Medical Device Starter Course, Part 6: ChatGPT For Medical Devices And Automating QMS Trainings

Medical Device Starter Course, Part 5: Auto-Generate Audit Spreadsheets For Requirements Management

Medical Device Starter Course, Part 5: Auto-Generate Audit Spreadsheets For Requirements Management

Medical Device Starter Course, Part 4: Saving Time By Copying OpenRegulatory Templates

Medical Device Starter Course, Part 4: Saving Time By Copying OpenRegulatory Templates

Custom File Documents / Records

Custom File Documents / Records

QMS Trainings: Automatically Train Your Employees in Formwork

QMS Trainings: Automatically Train Your Employees in Formwork

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

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

Manage your Technical Documentation in Formwork (eQMS software)

Manage your Technical Documentation in Formwork (eQMS software)

Medical Device Starter Course, Part 3: What next? How to save money and automate things?

Medical Device Starter Course, Part 3: What next? How to save money and automate things?

Medical Device Starter Course, Part 2: What do you need to do? Looking at IEC 62304 and other docs

Medical Device Starter Course, Part 2: What do you need to do? Looking at IEC 62304 and other docs

Medical Device Starter Course, Part 1: How much does it cost? How long does it take?

Medical Device Starter Course, Part 1: How much does it cost? How long does it take?

Creating a UDI For a Medical Device at IFA

Creating a UDI For a Medical Device at IFA

Registering at GS1 To Purchase a UDI For A Medical Device

Registering at GS1 To Purchase a UDI For A Medical Device

Introduction To Understanding Unique Device Identifiers (UDIs) For Medical Devices

Introduction To Understanding Unique Device Identifiers (UDIs) For Medical Devices

Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance)

Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance)

Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)

Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)

How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?

How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?

Medical Device Software Development: Introduction To The IEC 62304

Medical Device Software Development: Introduction To The IEC 62304

Hardware Medical Devices in Formwork

Hardware Medical Devices in Formwork

Formwork vs GitHub, Jira, ClickUp, Asana

Formwork vs GitHub, Jira, ClickUp, Asana

AI-Assisted Writing of Technical Documentation

AI-Assisted Writing of Technical Documentation

Manage Your Medical Device CAPAs in Formwork (eQMS)

Manage Your Medical Device CAPAs in Formwork (eQMS)

Formwork: Auto-Generate Your Technical Documentation With The New Audit Export

Formwork: Auto-Generate Your Technical Documentation With The New Audit Export

Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)

Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)

Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance)

Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance)

Writing a Quality Manual For Medical Device Quality Management (ISO 13485)

Writing a Quality Manual For Medical Device Quality Management (ISO 13485)

The Magical Wizard and How It Helps You

The Magical Wizard and How It Helps You

SaMD Meetup #11: Post-Market Surveillance

SaMD Meetup #11: Post-Market Surveillance

Automate Your Medical Device Risk Management With Formwork, An eQMS (ISO 14971 Compliance)

Automate Your Medical Device Risk Management With Formwork, An eQMS (ISO 14971 Compliance)

Audit Export and Sanity Check

Audit Export and Sanity Check

IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD)

IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD)

Employee QMS Training For ISO 13485 Compliance, Using eQMS Software

Employee QMS Training For ISO 13485 Compliance, Using eQMS Software

ISO 13485 - Compliant Handling Of Records, Save Time Using OpenRegulatory Templates

ISO 13485 - Compliant Handling Of Records, Save Time Using OpenRegulatory Templates

FDA and EU - Complaint E-Signatures: Documents and Review Workflow in eQMS Software Formwork

FDA and EU - Complaint E-Signatures: Documents and Review Workflow in eQMS Software Formwork

Introducing Formwork

Introducing Formwork

OpenRegulatory Workshop at Digital Medicine Conference 2021

OpenRegulatory Workshop at Digital Medicine Conference 2021

Kicky van Leeuwen: AI in Radiology, Current State of Play

Kicky van Leeuwen: AI in Radiology, Current State of Play

Ivo Flipse: Software Requirements Management

Ivo Flipse: Software Requirements Management

Ben Meier: Internal Audit in a Nutshell

Ben Meier: Internal Audit in a Nutshell

Dr. Oliver Eidel: Agile Development of Medical Devices

Dr. Oliver Eidel: Agile Development of Medical Devices

Natascha Cuper: Common Findings in SaMD Applications and Notified Body Expectations

Natascha Cuper: Common Findings in SaMD Applications and Notified Body Expectations

Martin Witte: Digitalization of Technical Documentation

Martin Witte: Digitalization of Technical Documentation

Astrid Ottosen: Supplier Evaluation of Medical Annotators for AI SaMD

Astrid Ottosen: Supplier Evaluation of Medical Annotators for AI SaMD

Jouke Waleson: What's so hard about building Medical Devices for consumers?

Jouke Waleson: What's so hard about building Medical Devices for consumers?

Audience Questions and Discussion

Audience Questions and Discussion

Dr. Johannes Tanne: Using git for QMS Document Control

Dr. Johannes Tanne: Using git for QMS Document Control

Dr. Oliver Eidel: Opening Talk

Dr. Oliver Eidel: Opening Talk

Pat Baird: An AI Medical Device Global Status Update (ISO, IMDRF, Legislation)

Pat Baird: An AI Medical Device Global Status Update (ISO, IMDRF, Legislation)

Leon Doorn: Risk Management in Decision Support Systems

Leon Doorn: Risk Management in Decision Support Systems

Documenting Failure Modes for ISO 14971 (Risk Management For Medical Devices)

Documenting Failure Modes for ISO 14971 (Risk Management For Medical Devices)

Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices)

Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices)

Creating a Simple Risk Table for ISO 14971 (Risk Management For Medical Devices)

Creating a Simple Risk Table for ISO 14971 (Risk Management For Medical Devices)

Creating a List of Hazard-Related Use Scenarios for IEC 62366 (Usability For Medical Devices)

Creating a List of Hazard-Related Use Scenarios for IEC 62366 (Usability For Medical Devices)

Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)

Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)

Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance)

Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance)

Documenting Software of Unknown Provenance (SOUP) for IEC 62304

Documenting Software of Unknown Provenance (SOUP) for IEC 62304

Dr. Oliver Eidel bei der Digital Medicine Week 2021 vom health innovation hub (hih)

Dr. Oliver Eidel bei der Digital Medicine Week 2021 vom health innovation hub (hih)