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

title: "Courses"

date_format: "2006-01-02"

item:
- organization: "KEY2COMPLIANCE AB"
  organization_url: https://key2compliance.com/
  title: "Device Control Training"
  date_start: "2019-09-16"
  date_end: "2019-09-17"
  description: >
    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: "KEY2COMPLIANCE AB"
  organization_url: https://key2compliance.com/
  title: "Software development - regulatory requirements"
  date_start: "2019-09-21"
  date_end: "2019-09-23"
  description: >
    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: "medicaldeviceHQ"
  organization_url: https://medicaldevicehq.com/
  title: "Risk Management for Medical Devices and ISO 14971:2019"
  date_start: "2024-02-23"
  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.

---