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Complimentary Webinar

June 22, 2021 | 12:00 p.m. - 1:00 pm ET

Are You Reg. Ready?

Getting Your Medical Affairs Team Primed to Manage New Regulatory Requirements

There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures.  But what of organizational change management readiness?  How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?

Join us for a behind the scenes look at how one company is managing change within their organization.  Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements.   Also joining Imelda will be Laurie Mitchell, Founder and President of Criterion Edge, a medical device regulatory writing service provider, who will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.

Learning Objectives:

During this webinar, you will learn:

  • Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
  • How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
  • Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.

Who Should Attend:

  • Medical Device & Diagnostics Professionals (from small-medium sized to large enterprises)


Dr. Imelda Omana-Zapata
Senior Manager, Clinical Projects

Imelda Omana-Zapata, MD, PhD is a Medical Affairs professional with experience in the Biotechnology industry. Before working as Senior Manager, Clinical Projects at BD Biosciences, she held clinical operations and drug discovery roles in various Biotech companies in the Bay Area. Imelda pursued academic research for several years. Completed her Doctorate degree in Neuroscience and taught at the National Autonomous University of Mexico.

Imelda’s passion for research is the source and motivation for her deep dive into medical product development with the purpose of improving technology for patient care. Imelda has been a part of teams achieving this goal and launch of various BD Biosciences products in the market. Recently, she and her team have contributed to the implementation of process and procedures to comply with the IVDR to obtain CE-IVD registration.

Additionally, Imelda has been both author and co-author in peer-review publications. Outside work she makes time for youth tutoring, friends, watercolor painting, and gardening.

Laurie Mitchell
Founder & President
Criterion Edge

Laurie Mitchell is Founder and President of Criterion Edge, a global medical and regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. Laurie has over 20 years of experience in medical writing,  safety and pharmacovigilance management, and regulatory reporting.

Having provided regulatory solutions to many pharma and medical device companies, both large and small, she is a proven leader in designing practical strategies to meet current global regulatory challenges. Laurie is a published author, and holds a Master of Nursing from UCLA.

Maria Fontanazza

Maria has more than a decade of experience in journalism, marketing, and communications within the publishing, conferences and medical device industry. She has authored more than 250 articles that have appeared in domestic and international industry publications and has moderated educational sessions and panel discussions at industry events. Maria joins Innovative Publishing from Secant Medical, Inc., where she was the Marketing Communications Manager and Market Research Manager. Maria has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT.


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