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Design Planning, Design History Files and Design Reviews

This course strengthens the ability to structure design planning activities, maintain usable Design History Files, and conduct disciplined design reviews that support compliant development decisions, clearer management oversight, and more reliable documentation practices throughout medical device product development. Designed for professionals responsible for medical device development documentation, review activities, quality processes, and compliance.

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US $190 per learner

30-Days Unlimited Streaming Access

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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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  • Instructor : Alan M. Golden
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3596
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Design planning establishes the structure needed to manage medical device development activities, related documentation, and milestone approvals throughout a project lifecycle. Inadequate planning or poorly maintained records can create gaps in traceability, delay submissions, and complicate management oversight. Proper organization of Design History Files supports retrieval of development records, including design inputs, outputs, verification, validation, and documented changes associated with product realization.


Design reviews provide formal checkpoints for evaluating progress against defined objectives while giving management visibility into delays, risks, resource constraints, and release readiness. Attention is also given to the structure and maintenance of Design History Files, subordinate planning activities, and review practices used to support consistent design control execution. The course addresses practical considerations tied to document accessibility, record organization, review participation, and approval responsibilities that influence product quality, regulatory expectations, and long-term support of on-market medical devices.

  • Stronger Control Over Development Activities:

    Clear planning practices and organized Design History Files improve visibility across development stages, supporting timely decisions, documented accountability, and better coordination between design, regulatory, and production activities. The material also clarifies how structured records and milestone reviews can reduce operational confusion during inspections, product changes, and release preparation.

  • More Effective Design Review Execution:

    Defined review processes help organizations evaluate project status, identify unresolved issues, and document management approvals at critical stages of development. Attention to review participation, approval responsibilities, and risk considerations supports stronger decision-making and helps teams respond more effectively when delays, design changes, or verification concerns affect development timelines or product release activities.

Key Areas Covered

  • Design control flow and planning activities within medical device development
  • Structure, organization, accessibility, and maintenance of Design History Files
  • Documentation practices for design inputs, outputs, verification, and validation activities
  • Change control management and record maintenance throughout the design process
  • Purpose, timing, participation, and approval responsibilities within design reviews
  • Risk assessment considerations connected to product quality and design evaluation
  • Management oversight, milestone tracking, and release readiness during development projects
  • Practical examples addressing documentation challenges, review outcomes, and project delays

Who Must Attend

  • Quality Assurance Teams
  • Regulatory Affairs Departments
  • Research & Development Professionals
  • Manufacturing & Engineering Teams
  • Product Development Professionals
  • Design Engineers
  • Compliance Departments
  • Clinical Affairs Professionals

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

ALAN M. GOLDEN

Alan M. Golden possesses extensive industry experience spanning medical device research, quality assurance, and regulated manufacturing support. During his tenure at Abbott Laboratories, he managed activities involving design control, validation, CAPA, change management, and risk management for new and existing products. He has also delivered global training programs focused on verification, validation, statistical methods, and regulated quality system requirements.

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Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

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Your organization deserves the confidence.

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“Structure helped. Otherwise this topic can get messy quickly.”


Validation Specialist, QA/IT

“Presenter knew where to spend time and where to move quickly. That made a difference.”

Director, Quality Assurance

“Flow was good. You could see the structure behind it. Not just information dump.”

Engineer, Production

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