This course focuses on how to design a process for the development and maintenance of medical device software according to the IEC 62304 standard and the regulatory requirements that apply to medical device software.
Topics
- Current software practices
- Designing high quality software in a regulated environment
- Standards for regulatory compliance
- Implementation examples for achieving compliance
- Practical applications of the requirements of the 62304 standard
- Some possible future changes within the medical device software field
Target group
This course is targeted towards professionals working with the development of medical devices containing software or software as a medical device (SaMD), with risk assessment of software-based products, quality assurance, process improvements, with the purchasing of software development from subcontractors, or purchasing software components.
Educational goals
After the course, participants will have an understanding of how to employ design processes for medical device development based on the 62304 standard, in order to achieve regulatory compliance and how to design high quality software in a regulated environment.
Recommended prior knowledge
A basic understanding of the medical device regulations (for example https://en.wikipedia.org/wiki/Medical_device) and some product and software development experience is recommended.
Course presentations
Course material will be in English, verbal presentation and discussions in Swedish or in English, depending on the participants.
Course leader
Robert Ginsberg, Chairman of the board, Principal Consultant
Dates and location
Lund
To be decided / On request
Stockholm
To be decided / On request
Online
To be decided / On request
Prices
SEK 14 500:-
All prices excl. local VAT (moms).
Group registration for QAdvis managed courses
For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
Registration
The course is organised in collaboration with Intertek Academy and will be held onsite.
Do you want to know more about this course? You are welcome to contact us at utbildning@intertek.com for more information.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.