Special Interest Groups - Medical Devices
Let’s talk about ISO13485v 2016 to ensure Safety & Quality in Medical Devices
- Delivered virtually as a Zoom Webinar
21 March 2023 (07.00 EDT- 11.00 UTC- 12.00 CET)
Free webinar for ISoP members, organized by the Medical Device Safety SIG and presented by Koudoua Djerafi, consultant & lead auditor ISO 13485v2016 (Algeria).
- Click HERE for the flyer.
- This webinar is for members. If you are not a member of ISoP and would like to attend this webinar, please visit our ‘How to Join’ page and join us!
ISoP SIG on Medical Device Safety
We have created the Medical Device Safety Special Interest Group to provide a forum for members to share experiences to suggest and discuss best practices and policy in the field of medical device performance monitoring and safety surveillance.
After a first start in 2018, the SIG on Medical Device Safety was officially launched at the General Assembly during the 20th ISoP Annual Meeting in Muscat, Oman (8-10 November 2021).
1. Develop a more proactive approach towards the safety surveillance of medical devices.
2. Initiate awareness on recall systems for the medical device products.
3. Create and maintain a forum for communication and collaboration between ISoP members and collaborators to address issues and challenges pertaining to safety of medical devices.
4. Advance in the field of medical devices through expanded use of safety surveillance.
5. The SIG members communicate, meet, develop training materials, develop position papers and publications, support students, and organize programming ideas.
➢ Discussion and awareness about recent changes in Medical Device Safety regulation changes in Europe, USA, Canada and other regions.
➢ Schedule participation and presentations of internal and external experts in Medical Device Development, Safety and Patient Advocacy (Regulators, Academia, Industry)
➢ Develop cross-functional relationship with other SIGs: Medication errors, Professional Qualification and Women medicines.
➢ Collaborate with ISoP chapters to participate and present SIG objectives, to develop trainings and organize webinars.
Advisory Role of the SIG
There are numerous issues relating to medical device manufacturing and those of us who are SMEs in this area believe much change is needed. A key role of this SIG will be to identify and collate these issues, develop an “issues agenda” and determine the necessary action to be taken. This is done through raising awareness of these issues by writing editorials, articles related, for international journals, professional organisations. The SIG will be committed to work as a repository to develop guidelines, recommendations and other solutions.
Membership of the ISoP SIG
Any member of ISoP with interest in medical device technology and safety is welcome to join the SIG. We are expecting and hoping the group will attract members from different countries and continents. We are expecting a good representation from countries who are strong in medical technology.
Mode of Communication
Meeting once every two months using web-based tool (Zoom)
If you would like to join the Medical Devices group, please contact Omar Aimer.