Medical Devices Technology & Regulation
March 22, 2018
Camilo (Green House), 24, Dr. George Wise St., Tel Aviv
The most focused event for the medical devices sector!
Uniquely tailored for medical devices professionals.
We offer free registration for medical devices professionals, working for local medical devices companies.
Why should you attend the Medical Devices Technology & Regulation conference:
- Come and meet the Who's Who in the medical devices space
- Get the most updated current technology and know-how from leading vendors
- Get the most updated current regulation and clinical know-how from leading vendors
- Best networking event
- Enjoy the unique ambiance and quality of SemIsrael professional events
*** Please note the dual track structure of the conference: Design Track, and Regulation Track (detailed agenda of both tracks below)
Please note that registration to the conference is now closed, while registration to Gsap workshop (starting 14:30) is still open.
Come & Meet Our Exhibitors:
Exhibition Map & Tables Allocation
Agenda: Design Track
Moderator: Amir Shiner, VP Medical Device Development , ARAN R&D
Agenda: Regulation Track
Moderator: Dr. Sigalit Ariely-Portnoy, CEO, Gsap
Gsap Workshop: Regulatory Challenges & News, the practical approach
timing: 14:30 - 16:00
To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the regulator constantly revises the requirements. In 2018 we are in the eye of the storm: from ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes are rampant and significant for medical device professionals. In the workshop we will review practical issues for implementing these requirements in the fields of usability studies, a Critical-To- Quality program and risk management requirements. Hopefully, you will get ideas that will let you safely land on shore.
1. QA/RA Challenges and Changes in 2018 (Dr. Sigalit Ariely-Portnoy, CEO) - 15 min
Last call to ISO 13485:2016 certification
First call to MDR implementation
ISO 14971 revisions
"Shift from compliance to quality focus" – What does it mean?
The moving target: MD SAP dead-line
2. Usability Focused on Human Factors (Tamar Fuerst, Practical Engineer, ICQE, Medical Device Regulatory Project Manager) - 15 min
3. Establishment of Critical-To-Quality Program (Marina Lebel, B.Sc, CQE, Medical Device Section Manager) - 15 min
4. New Tool For a Practical Approach to The Risk Management Requirements (Ossie Milanov, BA, Medical Device Quality & Regulatory Project Manager) - 15 min
5. Summary (Dr. Sigalit Ariely-Portnoy, CEO)