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Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements

About

Date/Time

September 9, 2020

Access On-Demand Webinar Here.

Following the publication of ISO 14971:2019 and the forthcoming EU MDR/IVDR regulations, additional requirements for post-market surveillance (PMS) have been defined within these standards. The updated standards call for a more defined PMS plan per product line, including parameters of required trending related to reporting. Additional specific actions that must be taken, based on the outcome of PMS activities, are also interpreted within the standards.

While no clear compliance date for ISO 14971:2019 has been announced, the EU MDR and IVDR are set to become effective in May 2021 and May 2022, respectively. However, it is recommended that Sponsors comply with these updates early and in an efficient manner to deliver maximum benefit throughout the medical device development process.

NAMSA invites you to join us for our webinar to review the new requirements for PMS and to learn best practices and considerations throughout the process.

Learning Objectives:

  • Understand the new requirements of post-market surveillance found in ISO 14971:2019 and the EU MDR and IVDR
  • Identify the actions you must take to meet these new/updated requirements
  • Discover effective approaches that can be implemented in your quality system

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Speaker

Linda Mummah-Schendel

Principal Quality Consultant

Linda Mummah-Schendel has over 30 years of regulatory experience in the medical device industry. She has developed, implemented and trained on new and re-engineered Quality Systems, including projects related to continuous improvement, product non-conformance, CAPA systems and root cause analyses. She has led multiple project management and development activities for a wide variety of medical devices and combination drug/devices, including IVD and biopharmaceutical products. An expert in GMP regulation and ISO 13485 Quality System requirements, Ms. Mummah-Schendel also has extensive knowledge and experience surrounding IDE and PMA submissions.