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Design Control For Medical Devices And Combination Products

This course strengthens the ability to structure design control activities that align user needs, product requirements, and regulatory expectations for medical devices and combination products. Participants will improve decision-making during product development while reducing compliance gaps that can delay approvals. This Course is designed for professionals involved in regulated product development, quality systems, compliance oversight, and design documentation activities.

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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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  • Instructor : Alan M. Golden
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3594
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Design control remains a critical requirement for medical device manufacturers and organizations developing combination products with device components. Weak control over design activities can affect product suitability, delay regulatory submissions, and create deficiencies during FDA or CE mark reviews. Clear documentation of user needs, product requirements, and design inputs forms the foundation for consistent product development and regulatory acceptance.


The program examines the operational flow of design control and the regulatory expectations connected to design inputs and product requirements. Particular attention is given to translating user needs into measurable requirements that support verification and validation activities later in development. The session also reviews 21 CFR Part 820 Subpart C requirements and explains why structured design control processes are necessary throughout device design. Organizations responsible for regulated development activities must maintain traceable and controlled design practices to support product quality, compliance, and market readiness.

  • Strengthen Design Input and Requirement Definition:

    Accurate translation of user needs into product requirements directly affects device performance, usability, and regulatory acceptance. This course clarifies how design inputs are established and documented within the design control process, helping organizations reduce inconsistencies that often surface during development reviews, verification activities, and regulatory inspections involving medical devices and combination products.

  • Improve Regulatory Readiness During Product Development:

    Regulators expect organizations to maintain structured design control activities throughout device development. This course provides practical understanding of FDA and CE mark expectations tied to design controls, including 21 CFR Part 820 Subpart C requirements. Clearer alignment between development activities and regulatory expectations can reduce approval delays, documentation deficiencies, and product development exposure.

Key Areas Covered

  • Overview of design control principles for medical devices and combination product device components
  • 21 CFR Part 820 Subpart C requirements related to design control activities
  • Importance of controlled design processes during regulated device development
  • Regulatory expectations from FDA and CE mark perspectives
  • User needs as the foundation of design input activities
  • Translation of user needs into defined product requirements
  • Development flow of design control from initial inputs through subsequent stages
  • Next steps associated with managing and refining design inputs

Who Must Attend

  • QA/QC Departments
  • Regulatory Affairs Teams
  • Research & Development Professionals
  • Manufacturing, Engineering & Operations
  • Production Departments
  • Scientists

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

ALAN M. GOLDEN

Alan M. Golden has built a long-standing career in medical device research, quality assurance, and regulated product development. At Abbott Laboratories, he supported design control, validation, change control, CAPA, and risk management activities across both development and commercial product operations. His experience also includes quality oversight for diagnostics and molecular divisions, supported by international training work in validation, statistics, and quality system practices.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

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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