Practical Solutions for Medical Device Design History File (DHF) Construction and Maintenance

Design history files (DHF) need to be developed for every marketed device, beginning at the product’s inception, as this document serves as a means of providing the FDA and other regulatory authorities with evidence which demonstrates a full understanding of the product’s development. A number of reports and forms should be compiled within the DHF including the approved design plans, product specifications, validation and verification, as well as any changes made throughout the device lifecycle. While this process may seem straightforward, many device quality and regulatory professionals struggle with organizing these documents accurately and thoroughly. With a recent spike in related warning letters and enforcement actions, device manufacturers must ensure they have a precise and up-to-date DHF for each device they market.

  • FDA DHF requirements and expectations
  • Crafting traceability matrices
  • Takeaways from recent 483’s
  • Pros and cons of paper versus software
  • Determining DHF ownership and management
  • Tips for mitigating documentation pitfalls


Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Medical Device Reporting
  • Post-Market Surveillance
  • Quality Systems







Matthew Walenciak
Senior Director, Quality Engineering & Post-Market Compliance


Matt Walenciak is the Senior Director of Quality Engineering and Post-Market Compliance at ConvaTec.  This position is responsible for design assurance quality engineering, complaint handling, post-market surveillance, continuous improvement, and portfolio/project management. Matt has also held roles within product development project management and operations at ConvaTec.  Prior to working at ConvaTec, Matt was at Becton Dickinson (BD) in product development engineering and project management roles.  Overall, Matt has 20+ years experience in medical devices across development, operations, and quality functions.  Matt has a BS in Mechanical Engineering from Virginia Tech, a MS in Mechanical Engineering from Rutgers University, and an MBA from Seton Hall University.


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