BSI and its US collaboration partner AAMI are very pleased to announce dates for their 2020 International Conference on Regulations and Standards. Due to COVID19, the conference goes virtual.
We have assembled a speaker faculty from the UK MHRA, US FDA, BSI’s global medical devices EU Notified Body, UK National Standards Body and industry experts all speaking on important topics impacting on regulatory compliance.
For this year we have taken Patient Safety as our conference theme, along with Human Factors and Usability rapidly have become of greater significance in our Medical Devices Sector, something we should all take note of and recognise.
The implementation date of the EU Medical Devices Regulation (MDR) [2017/745/EC] is approx. 4 months away in May 2020. With the conference being held just a few weeks after the MDR implementation, hear from the UK MHRA on the latest UK Medical Devices legislation and the way forward post-Brexit, US FDA describing different industry related programmes including highlighting progress on the ISO13485/QSR transition. From BSI’s European Notified Body, hear the latest information affecting your compliance programs, MDR lessons learnt so far, complimented by industry representatives sharing their own MDR experience as a means for you and others to learn and consider how the lessons can be applied to readiness activities for the in vitro diagnostic medical devices regulation (IVDR).
Other topics include detailed sessions covering Developments in Regulations and Standards for risk management, Clinical Investigations, Sterilization, Regional Regulatory updates, Software, Cybersecurity, Machine Learning, Artificial Intelligence.
This conference will provide the opportunity to engage with the speakers and provide you with further knowledge, understanding, and interpretation which will help everyone involved with their companies’ medical devices conformity assessment programs from your junior staff to the Head of the Global Regulatory and Quality activities.