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Reverse Engineering Medical Device Design Outputs

This course strengthens the ability to reconstruct compliant design outputs from existing device information, improving traceability, remediation planning, and post-market integration for more consistent documentation decisions across legacy and current medical device programs. This Course is designed for professionals responsible for medical device development documentation, remediation activities, and quality system support.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF1302
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Medical device manufacturers working with legacy and newly developed products frequently encounter gaps between existing documentation and current regulatory expectations for design outputs. When outputs are incomplete, outdated, or poorly connected to design inputs, organizations can face difficulties during internal reviews, remediation efforts, and ongoing quality system activities. Clear documentation practices supported by traceability and existing product information are necessary to maintain consistency across development records and post-market activities.


The course addresses practical methods for building design outputs from information sources manufacturers may already possess, including post-market data and existing development records. Attention is given to identifying situations requiring remediation, establishing traceability between design inputs and outputs, and incorporating relevant post-market findings into the Design History File. These activities support stronger continuity between development documentation, product experience, and quality processes aligned with ISO 13485 and 21 CFR Part 820.30 requirements.

  • Improve Design Output Remediation Decisions:

    Organizations managing legacy devices or incomplete records often need to reconstruct design outputs without disrupting existing quality processes. This course clarifies how to use available development information, post-market findings, and traceability practices to support remediation activities while maintaining clearer links between design inputs, outputs, and documented product history.

  • Strengthen Traceability and DHF Continuity:

    Disconnected design records can create review delays and uncertainty during quality or regulatory assessments. The course explains practical approaches for connecting design inputs to outputs through traceability matrices and incorporating post-market information into the Design History File, supporting more consistent documentation maintenance and ongoing evaluation activities across device lifecycles.

Key Areas Covered

  • Design outputs from the perspective of ISO 13485 and 21 CFR Part 820.30
  • Situations where medical device design outputs may require remediation
  • Existing manufacturer information sources used to develop design outputs
  • Use of post-market data to support design output development activities
  • Development of traceability matrices linking design inputs and design outputs
  • Integration of post-market information into the Design History File for ongoing documentation continuity

Who Must Attend

  • Quality Assurance Departments
  • Engineering & Design Teams
  • Regulatory Affairs Departments
  • Research & Development Teams
  • Manufacturing & Production Departments
  • Compliance Professionals
  • Scientists

Quality training, expert insights, and answers that matter. Know your Expert

KATE KEITH

Kate Leith has more than 30 years of experience across medical device and IVD product development, post-market activities, technical support, and quality system processes. Her work supporting FDA QSR processes, EU regulations, audits, and manufacturer training directly relates to the documentation and remediation challenges addressed in this course. Through consulting roles with start-ups and multinational manufacturers, she has worked extensively with development records, quality activities, and regulatory expectations connected to medical device design documentation.

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