---
widget: "accomplishments"
headless: true
weight: 45

title: "Courses"

date_format: "2006-01-02"

item:
- organization: "Key2Compliance"
  organization_url: https://key2compliance.com/
  title: "Device Control Training"
  url: /pdf/certificates/DesignControlTraining.pdf
  date_start: "2019-09-16"
  date_end: "2019-09-17"
  description: >
    Course content:
     - Medical devices - EU
     - Combination products
     - Quality system strategy
     - Design Controls
     - Planning
     - User needs -> Design input
     - Risk management
     - Design Output, Review, Verification, Validation, Transfer, Changes
     - Design History File

- organization: "Key2Compliance"
  organization_url: https://key2compliance.com/
  title: "Software development - regulatory requirements"
  url: /pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf
  date_start: "2019-09-21"
  date_end: "2019-09-23"
  description: >
    Course content:
      - EU Medical Device Regulation (MDR)
      - 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 
      - Software risk in relation to 62304 
      - Concept cybersecurity 
      - Cybersecurity risk management process 
      - Agile SW development 
      - GDPR/HIPAA 
      - Tool validation 

- organization: "medicaldeviceHQ"
  organization_url: https://medicaldevicehq.com/
  title: "Introduction to Risk Management for Medical Devices and ISO 14971:2019"
  url: /pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf
  date_start: "2024-01-10"
  description: >
    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: "medicaldeviceHQ"
  organization_url: https://medicaldevicehq.com/
  title: "Risk Management for Medical Devices and ISO 14971:2019"
  url: /pdf/certificates/RiskManagementforMedicalDevicesandISO14971_2019.pdf
  date_start: "2024-02-23"
  description: Blended classroom and online training.

- organization: "medicaldeviceHQ"
  organization_url: https://medicaldevicehq.com/
  title: "Introduction to Safety for Electrical Medical Devices and IEC 60601"
  url: /pdf/certificates/IntroductiontoSafetyforElectricalMedicalDevicesandIEC60601.pdf
  date_start: "2024-04-17"
  description: >
    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: "medicaldeviceHQ"
  organization_url: https://medicaldevicehq.com/
  title: "Introduction to SaMD, IEC 62304 and IEC 82304-1"
  url: /pdf/certificates/IntroductiontoSaMD,IEC62304andIEC82304-1.pdf
  date_start: "2025-01-14"
  description: >
    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

---