How to Establish and Maintain a Design History File for a Medical Device

Instructor: Mary Nunnally
Product ID: 705287
  • Duration: 60 Min
This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2017

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

This webinar will provide an overview of basic requirements for the content of a medical device Design History File (DHF) to ensure compliance with 21 CFR 820 and ISO 13485:2016 guidelines. It will review potential differences in the requirements between the two regulatory standards.

Attend this webinar to learn how the outputs of risk management activities can affect a medical device’s DHF. It will also cover methods for establishment and ongoing maintenance of the required records.

Areas Covered in the Webinar:

  • Records required for the Design History File.
  • Whose job is it to establish and maintain the Design History File?
  • How to maintain control over the Design History File documents?
  • What document control means for DHF documents (records)?
  • What are the responsibilities of various development team members – such as R&D/engineering, marketing, quality assurance, project management and executive management?
  • Do you consider a marketed medical device’s DHF a static record simply signed off and stored?
  • Link to other relevant design files, such as a medical device product Risk Management File

Who Will Benefit:

  • R & D Scientists
  • Project Managers
  • Quality Assurance Personnel
  • Document Control Personnel
  • Regulatory Affairs Personnel
  • Quality Engineers
  • Quality System Auditors
  • Marketing
  • Executive Management
Instructor Profile:
Mary Nunnally

Mary Nunnally
President, Translational Medicine LLC

Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

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