RAPS Member: $30
With the entry into force of the Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR) on 25 May 2017, new requirements impacting Postmarket Surveillance (PMS) have significantly raised the bar for manufacturers.
Continuous evaluation and improvement of devices is at the very heart of this change. The Regulations introduce requirements for active collection and analysis of postmarket experiences for legacy devices as well as new products, effective on the date of application for each regulation (i.e., no soft transition). New processes and governance will be needed to support this assessment and ongoing technical documentation updates for both the MDR and IVDR.
Come engage with professionals from your local regulatory community for an interactive session where you will learn strategies for planning and implementation of PMS requirements, including:
- Active data collection
- Identifying potential input sources
- Surveillance proportionate to risk and device type
- Gap analysis in current and future procedures
- Status of guidance and templates
- Postmarket clinical/performance Follow-up studies (PMCF/PMPF)
- Continuously monitor state of the art and clinical data
- Mechanisms to understand benefit-risk estimates, emerging off-label use, etc.
- Analysis and reporting requirements (PMS Report, PSUR, PMCF/PMPF evaluation reports)
- Linkage of postmarket data with other technical documents and departments/functions
- Resource requirements
- Triggers and techniques for actions
This program, hosted by AbbVie, is brought to you by the RAPS Chicago chapter to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits.
Mindy McCann, vice president regulatory compliance, Qserve Group