Updating Compliance for Design History Files of Older Products


Many regulated companies have not brought their old products up to current FDA standards and are not in total compliance. This webinar defines the criteria to be used for medical products design history file remediation. For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team. In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

  • Multi-functional team approach/responsibility.
  • Set procedures and template to complete remediation for design history file of old products to meet current standards.
  • Gap analysis.
  • Gathering of data to build the design history files.
  • Risk procedure.
  • Risk assessment for prioritizing remediation.
  • Traceability matrix.
  • Validations.
  • Dealing with the FDA.
  • Check list.

  • This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:
  • End-users responsible for design control and technical files that need to be updated to the current standards
  • R&D and product development engineers and managers.
  • Validation Engineers
  • Remediation teams
  • QA, Regulatory Affairs and team members who contribute to design history or technical files
  • Consultants
  • Corporate auditors

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