Know the essential EU MDR Portfolio planning requirements.
Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.
The time to plan is now.
You need to get information to your notified body to get on their schedule. The consolidation and disappearance of notified bodies has started. The notified bodies are sounding the alarm. Once there were 86 notified bodies and now there are less than 60 with a potential to go to less than 40. To make sure you have the reviews needed to keep your product on the market under the new regulation, you will need their review and the ones working with them to plan resources will get the priority.
This webinar will describe what information you need and the steps to creation of your portfolio plan. In addition, we will provide examples on how to communicate this to your notified body and what to expect as a response.
This is the first installment in a series of webinars dedicated to providing information on steps to be taken to obtain compliance with the new Medical Device Regulation. The series will include:
- Portfolio planning
- CER creation and remediation
- Technical documentation update and remediation
- Quality Management System update and connection to ISO 13485
- Post-market surveillance activities
- Risk management and the EU MDR
In this session we covered:
- Why do I need a portfolio plan?
- Key process steps
- Critical areas of focus
- Working with product managers
- Return on investment
- Case studies
- What to do: R&Q recommended next steps
- Learn what is expected by the notified bodies
- Know how it might impact my company and our products
- Understand immediate actions and potential next steps
- Practical tips and guidance for communication with your notified body
- Valuable insight from experienced industry leaders
Who should view?
This session is designed for medical device manufacturers who market medical devices in the European Economic Area.
Also, newly appointed medical device companies in areas of cosmetics, cosmetic lights/lasers, colored contact lenses, cleaning and disinfecting solutions, sub-dermal and trans-dermal implants are a good fit for this session.
Job functions include:
- C-Level Executives
- RA/QA Directors
- Quality Managers
- Regulatory Affairs Managers
- Regulatory Specialists
- Quality Specialists
- Quality Engineers
About the med device experts
Mark Swanson, Executive Director, Intelligence & Technical Excellence
Mark is R&Q's Director of Minnesota Operations / Principal Consultant - and is also a member of ISO Technical Committee 210 (TC210) and Working Group 1 (WG1). Additionally, he is a member of the MDIC Case for Quality Forum. Mark (CMQ/OE, CQE, CBA) has spent more than four years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016 and has also participated with ISO TC176, WG24 on ISO 9001:2015. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single quality management system.
Nancy Morrison, Director of Regulatory Affairs
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 solutions.