Course
has successfully completed the following online training course on March 8, 2024, titled:
Isabelle Gretas
Introduction to SaMD, IEC 62304 and IEC 82304-1
Peter Sebelius
Founder & CEO, Medical Device HQ AB
Course 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
The validity of the certificate and the qualifications of the course leader can be verified by contacting medicaldevicehq.com. Refer to certificate no 97113903
Certificate
Isabelle Gretas
This online course teaches you how to create and manage high quality, safe Software as a Medical Device (SaMD). It looks at the development aspects of the IEC 62304 standard and also includes an introduction to the IEC 82304-1 standard and its relation to ISO 13485 (quality management). You will also learn about the relationship to ISO 14971 (risk management) when developing medical device software.
Skills / Knowledge
- Software development
- medical devices
- IEC 62304
- IEC 82304-1
- software safety classification
- software risk management
- ISO 13485
- ISO 14971
- SaMD
Issued on
March 8, 2024
Expires on
Does not expire