In this training of 90 minutes, aimed at engineers that want to grow their understanding of working in a medical device industry, we discuss the essence of a quality system, why document controls, and provide an introduction to the IEC 62304 and ISO 14971 standards. With our background in systems and software engineering, we are often better able to translate the regulatory world in a way that makes sense to an engineer.
The expect results are:
- Participants can explain the essence of a quality system
- Participants understand the importance of appropriate training in a regulated environment
- Participants have a basic understanding of why compliance to standards is important in a regulated context
- Participants have a high-level understanding of the IEC 62304 and IEC 14971 standard
Topics
What are the responsibilities of a Medical Device Manufacturer?
- The essence of a quality system
- What is a quality procedure?
- What is a quality record?
- Training
- Why is training important?
- What are training records?
- What will auditors look for?
- Document controls
- The importance of approval order
- Design History File (DHF), DMR (Device Medical Record) & DHR (Device History Record)
- How to develop a DHF incrementally?
- How to write controlled documents.
- Systems thinking
- System boundaries / Intended use
- Solutions versus systems versus subsystems
- Standards
- Introduction of IEC 62304
- Introduction of IEC 14971
- Software level of concern & SOUP (Software of Unknown Providence)