| organization |
organization_url |
title |
url |
date_start |
date_end |
description |
| Key2Compliance |
https://key2compliance.com/ |
Device Control Training |
/pdf/certificates/DesignControlTraining.pdf |
2019-09-16 |
2019-09-17 |
Course content:
- Introduction
- Medical devices - EU
- Combination products
- Quality system strategy
- Design Controls
- Planning
- User needs -> Design input
- Risk management
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design Documentation ”DHF”
|
|
| organization |
organization_url |
title |
url |
date_start |
date_end |
description |
| Key2Compliance |
https://key2compliance.com/ |
Software development - regulatory requirements |
/pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf |
2019-09-21 |
2019-09-23 |
Course content: - EU Medical Device Regulation - FDA regulations - Good practice: SW lifecycle processes - 60601 with focus on chapter 14, contribution of SW to essential performance - 62304 - Software development lifecycle - Development For class C software - Short intro to risk management - ISO 14971 - Software safety class - Software risk in relation to 62304 - Concept cybersecurity - Cybersecurity risk management process - Agile SW development - GDPR/HIPAA - Tool validation
|
|
| organization |
organization_url |
title |
url |
date_start |
description |
| medicaldeviceHQ |
https://medicaldevicehq.com/ |
Introduction to Risk Management for Medical Devices and ISO 14971:2019 |
/pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf |
2024-01-10 |
Learning goals:
- To understand the overall process of risk management and how to create safe medical devices.
- To strengthen the ability of participants to independently perform risk analysis, risk evaluation and risk control.
- To establish and increase knowledge on risk management tools and their differences, such as FMEA and P-FMEA.
|
|
| organization |
organization_url |
title |
url |
date_start |
description |
| medicaldeviceHQ |
https://medicaldevicehq.com/ |
Risk Management for Medical Devices and ISO 14971:2019 |
/pdf/certificates/RiskManagementforMedicalDevicesandISO14971_2019.pdf |
2024-02-23 |
Blended classroom and online training. |
|
| organization |
organization_url |
title |
url |
date_start |
description |
| medicaldeviceHQ |
https://medicaldevicehq.com/ |
Introduction to Safety for Electrical Medical Devices and IEC 60601 |
/pdf/certificates/IntroductiontoSafetyforElectricalMedicalDevicesandIEC60601.pdf |
2024-04-17 |
Learning goals:
- Understand what basic safety for a medical device is.
- Understand why and how basic safety is implemented and the most common pitfalls in medical device product development and how to avoid them.
- Strengthen your communication skills in the area of basic safety for medical devices.
- Build awareness of effective management of safety throughout the product lifecycle.
|
|
| organization |
organization_url |
title |
url |
date_start |
description |
| medicaldeviceHQ |
https://medicaldevicehq.com/ |
Introduction to SaMD, IEC 62304 and IEC 82304-1 |
/pdf/certificates/IntroductiontoSaMD,IEC62304andIEC82304-1.pdf |
2025-01-14 |
Learning goals:
- Know how to create high quality software
- Know how to create safe software
- Be able to manage software in a way that adds value to you
|
|
