Course
has successfully completed the following online training course on July 19, 2024, titled:
Tsz Lok Keith Tang
Introduction to Medical Device
Requirements Engineering
Peter Sebelius
Founder & CEO, Medical Device HQ AB
Course learning goals:
- Recognise and categorise different types of requirements
- Effectively define and document proper user needs and design inputs for a medical device
- Understand how requirements can be documented, managed and changed
The validity of the certificate and the qualifications of the course leader can be verified by contacting medicaldevicehq.com. Refer to certificate no 109346763
Certificate
Tsz Lok Keith Tang
This online learning course teaches you how to define user needs and translate them into design input requirements that meet the needs of patients, healthcare providers, regulators and other key stakeholders. It also teaches you how to categorise requirements, manage changes to requirements, and ensure that requirements can be verified or validated.
The course is based on requirements engineering best practices, ISO 13485 and QSR requirements and it covers the entire process of requirements engineering from user needs to design input requirements. It also also covers the importance of traceability.
Skills / Knowledge
- Medical devices
- ISO 14971
- user needs
- design input requirements
- ISO 13485
- QSR
- traceability
- change management
- requirements engineering
- product development
Issued on
July 19, 2024
Expires on
Does not expire