Program Management for IVDR and EU MDR

Get right to it → This webinar will cover tips, tricks, and lessons learned for successful program/project management of your transition to IVDR or EU MDR certification.

A little more detail...

We all still have our day jobs, right? New product development, sustaining design changes and issues, day-to-day regulatory support…we’re all busy! And now we have to get IVDR certified? How can we do it all? The solution is effective program management. Whether you’re just starting to plan your IVDR program (or not sleeping well because you haven’t started yet), or well into EU MDR but ready to plan PMS activities, this webinar will be helpful. We’ll discuss keys to success and stories from our projects at every phase, including that critical initiation phase that teams often skip over. Resource and communication plans, detailed schedules by product family, metrics, and dashboards are musts for large programs with limited resources. Join us and pick up some tips on how increase the odds of success for your program.

Presenters

Aurora Hill, MS, MBA, PMP – Senior Project Manager
Regulatory & Quality Solutions (R&Q)

Aurora Hill, a certified project management professional, has 14 years of experience developing, commercializing and sustaining medical device technologies. She has supported several business functions such as corporate development, research and development, operations and business development to lead teams that deliver solutions that meet technical requirements, regulatory requirements and corporate strategic initiatives. Aurora has a master’s degree in biomedical engineering and a master’s in business administration.

Ruthanne Vendy – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q)

Ruthanne has been a medical device regulatory professional for more than seventeen years, with experience in multiple medical specialties. Ruthanne started her medical device career in product development with one of the world’s largest manufacturers of professional dental products. She migrated into regulatory affairs early in her career as an RA Associate, and quickly found her niche as an RA Specialist. She spent her last six years prior to joining R&Q as an RA Manager responsible for a diverse portfolio of surgical and dental devices. Ruthanne has worked for several companies in both corporate and manufacturing settings providing staff training, audit management (internal, notified body, and FDA), premarket and post-market support, global registrations and licensing, submissions, document control oversight, labeling/advertising approvals, and technical documentation. Ruthanne also served on the Material Review Board for her last company. She is Regulatory Affairs Certified (RAC) by RAPS, has a Bachelor’s degree in Organizational Management from Eastern University, and holds a Health Services Management Certification from Philadelphia University.

Johnna Dominick, MS – Associate Project Manager
Regulatory & Quality Solutions (R&Q)

Johnna is a project management professional with a Bachelor of Science degree in Chemistry and a Master of Science degree in Biochemistry. With over 5 years of experience working in the medical device industry, Johnna has experience with project management, QMS development and process improvement, post-market surveillance activities including complaint processing and trend analysis, CAPA management and support, adverse event reporting, and risk management. Her actionable skills pertaining to project management include the management of a wide range of research, technical writing, and regulatory projects. During her time at R&Q, Johnna’s focus has centered around managing projects related to the development of clinical evaluation reports (CERs) that meet the requirements of MEDDEV 2.7/1 Rev. 4 and EU MDR and performance evaluation reports (PERs) that meet the requirements of IVDR.