There is one month until your post-market surveillance (PMS)
system must comply with the EU MDR. How's it going?
We've heard loud and clear an abundance of last-minute
issues and questions. While there have been and will continue to be plenty of
implementation challenges, our Executive Director of Regulatory and Quality
Consulting Services has worked through comprehensive solutions and is prepared
to share them using several real-world examples. The presentation will include
examples of the following:
- Getting fully prepared for your notified body
- You should have PMS plans by now but what about
procedures? We’ll elaborate on critical
processes and how to optimize them for long-term success.
- The risks of doing a justification for PMCF and
does justification for not conducting PMCF work?
- Pressure testing your systems: how to gather all
the data sets and integrate them into cohesive PSURs and PMS Reports even when
the data sets are from disparate systems.
- Integrating your PMS program with CERs, risk
management, technical documentation, and labeling to optimize efficiency.
This webcast will go into detail about strategies to
overcome audit findings and gaps in your evidence. If you want to help optimize
every element of PMS/PMCF as it relates to the EU MDR at your organization, this
is the definitive session for you. All webcast attendees will leave with the
ability to impact their organizations, no matter where their organizations are
in the implementation process.
- Advanced: Content is designed for
individuals who are well-versed in most, if not all, concepts associated with
the topic(s). Activities place a high concentration on analysis and application
of concepts or demonstration of competencies through exercises such as case
studies, scenario building, and group projects. A high level of participation
is expected from each attendee.
- Identify requirements for PMS on the date of
applicability (26 May 2020) of the EU MDR.
- How to prepare for Notified Body (NB) audits
related to PMS and avoid common findings.
- Conduct an integrated review of systems to
ensure alignment across systems required to support or impacted by PMS.
Who Should Attend?
- Regulatory and quality affairs professionals
- Supply chain representatives
- Clinical affairs professionals
Nancy Morrison, executive director, regulatory and
quality consulting services, Regulatory & Quality Solutions (R&Q)
Nancy has over 25 years of quality and regulatory experience
in the medical industry with US and global regulatory submission experience.
The previous five years have been with R&Q working with start-up, mid-size
and multi-national medical device and combination product companies. Nancy has
a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory
Affairs along with RAC certifications for the US and EU. Nancy has the ability
to build collaborative relationships with stakeholders to utilize regulations
to identify opportunities that provide compliant and effective business
Webcast registration includes access to handouts,
presentation slides and the on-demand recording for one year.