This session will feature representatives of the GCC region’s major regulatory bodies who will speak about their national registration procedure, changes in the regulation and what they will be focusing on in 2020-2021.Question to discuss:
The European Union’s new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which replaces decades old legislation, requires manufacturers to make significant changes in product development, data reporting and quality assurance.
In the presentation the expert will explain the difference between MDD & MDR; speak about new classification of medical devices and discuss with the audience Industry challenges in meeting of MDR requirements.
There are different classification systems for Medical devices. Each country decide which one to follow but there are always questions related to certain products.
This session will be opened with the comparison analyse of different classifications and followed up by Experts discussion VKey presentation: GSO – New standards for Medical devices classification.
This session will be open buy Key presentations and followed by discussion:
Presentations: Overview of Quality management Systems for Medical devices Risk Management and the ISO standards 14971
After the session an Interactive Dialog with the Audience will be Accident Reporting as Safety requirement?
The pandemic has showed us how important are innovations, digitalisation, ehealth… but at the same time it highlighted the questions about Patient Safety, Counterfeit, Data protection, Cyber security.. This session will bring experts to discuss this one of the most important topic from different aspects and advise how we can bring innovations and digitalisation in our healthcare, enable electronical records but at the same time to increase security and patient safetyTopics to be discussed: