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Meeting FDA, EU MDR, & ISO Standards on Usability Engineering

Saher Bishara (Senior Principal Human Factors & Usability Engineer, Medtronic Diabetes)

Location: 210D

Date: Thursday, February 7

Time: 1:15pm - 2:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

While portfolio audits are part of life at medtech companies, compliance with a variety of industry regulations will require a deeper dive on the need for product redesign or documentation requirements. If your product is sold in the EU, chances are you will be going through design remediation on legacy products. Does the IEC 62366 standard which calls out the errors caused by inadequate medical device usability aligned with the new EU MDRs? And FDA has its own rules and documentation requirements. Come find out what areas have been impacted.

Topics covered include:
  • Updating the content of the technical documentation depending on product classification
  • Exploring the complexities of the technical file structure and where you should focus your efforts
  • Remediation strategies for documentation including the Design History File