ISO 13485: 2016 for Medical Device Manufacturers: Ensuring a Smooth Transition Through Effective Preparation

Medical Device, Medical Device Manufacturing & Supply Chain, Medical Device Safety and Regulation,
  • August 31, 2017

In 2016, significant revisions were made to the quality management standard ISO 13485, an internationally recognized standard for all medical device manufacturers. The updated changes to ISO 13485 – the first since 2003 – demonstrate the increasing Quality System requirements for the global medical device industry and how organizations must adhere to the forthcoming and revised standard.

Join NAMSA’s regulatory expert, Linda Mummah Schendel, Principal Medical Research Manager, as she discusses the steps that medical device manufacturers should take now to effectively prepare for the new standard by the mandatory implementation date in 2019.

This webinar will highlight best practices, suggestions and other information, including:

  • Understanding when medical device manufacturers will be required to comply with ISO 13485, and if there are any exceptions
  • Learning about the top ten changes that should be considered when identifying a compliance strategy
  • Discovering approaches that medical device manufacturers can utilize to effectively address the new standard
  • Understanding the role of risk management and how it may impact implementation
  • Uncovering, and maximizing, the benefits of ISO 13485

Speakers

Linda Mummah Schendel, Principal Medical Research Manager, NAMSA

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. Linda currently serves as NAMSA’s Principal Medical Research Manager.

Who Should Attend?

Department Heads/Senior Professionals working within:

  • R&D
  • Regulatory Affairs
  • Outsourcing

Xtalks Partners

Namsa

NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines — consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality — to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.

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