1
0

Shortening text
All checks were successful
ci/woodpecker/manual/build Pipeline was successful

This commit is contained in:
2025-10-30 20:43:34 +01:00
parent c5954d48f6
commit c2afd058f3

View File

@@ -16,7 +16,6 @@ item:
date_end: "2019-09-17"
description: >
Course content:
- Introduction
- Medical devices - EU
- Combination products
- Quality system strategy
@@ -24,13 +23,8 @@ item:
- Planning
- User needs -> Design input
- Risk management
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design Documentation ”DHF”
- Design Output, Review, Verification, Validation, Transfer, Changes
- Design History File
- organization: "Key2Compliance"
organization_url: https://key2compliance.com/
@@ -40,14 +34,12 @@ item:
date_end: "2019-09-23"
description: >
Course content:
- EU Medical Device Regulation
- 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
- Short intro to risk management - ISO 14971
- Software safety class
- Software risk in relation to 62304
- Concept cybersecurity
- Cybersecurity risk management process