ATX West, MD&M West, Plastec West, West Pack, and Design & Manufacturing West is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Meet FDA and EU MDR Requirements

Eri Hirumie (Regulatory Affairs Specialist, MicroVention)

Location: 210D

Date: Thursday, February 7

Time: 2:00pm - 3:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

The US FDA has focused on feeding the post market surveillance back into the design and development phases. Meanwhile there has been an increased emphasis on PMS and PMCF compliance initiatives under the new EU Medical Device Regulation. The clear regulatory trend is dispersing the post market information throughout the world. It is increasingly important to maintain information for a product throughout its complete lifecycle and ensure that the transparency of post market data is leveraged to ensure patient safety.

Topics covered include:
  • Confirm the availability of clinical data
  • Evaluate gaps in current data and identify a plan to correct deficiencies
  • Explore how to use existing data to support compliance world-wide
  • Managing the delicate balance of implementing changes to maintain state-of-the-art and keeping products safe and effective

Presentation File