Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations

  • 04-07 Oct 2022
  • Webinar

Description

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations is a course that covers topics such as:

  • The MEDDEV on Stand Alone Software
  • The Regulatory Framework
  • The Practical Construction of a Technical File
  • The Principles to Bring a Medical Device Software Product to the Market
  • FDA Guidance on Medical Device Software Systems and Mobile Apps
  • The US Code of Federal Regulations and its Implications for Software
  • The IEC and EN ISO Standards and their Applicability; including Risk Management and Usability
  • Key Information on Design Aspects of Medical Software
  • Design Activities; including Architecture Design , Configuration Management and Verification and Validation
  • The Fundamental Principles of Quality Management Design Control

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations brings together:

  • Internal / External Auditors and/or Consultants
  • Senior Management, Project Leaders
  • Quality Systems and Quality Assurance Personnel
  • Regulatory Affairs
  • New Product Development, Marketing
  • IT Managers
  • Document Control / User Manual Writers
  • Software Product and Process /Manufacturing Engineering Staff
  • R&D Software Engineering Team Members and GUI Designers

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations will be held on 04-07 October 2022.

More Details

Prices:
1599-1999 Pound Sterling (Estimated)
Organizer:
Management Forum
Website:

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Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device
Science: Life Sciences & Biology

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