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Design Control Training for Design & Development Requirements — $1295

Design Control Training

For Design & Development Requirements

Days: 2 • CEU Hours: 1.9

7:30 AM – 4:30 PM

 

Overview

In medical device and manufacturing industries, design controls are more than just a regulatory requirement. They form the foundation for developing safe, effective, and reliable products that meet customer needs while complying with global standards. Organizations that manage design controls effectively not only maintain compliance but also reduce risks, avoid costly redesigns, and ensure smooth product launches.

This two-day Design Control Training course, aligned with ISO 9001:2015, ISO 13485:2016, FDA 21 CFR 820 (QMSR), and EU MDR 2017/745, gives you the skills and knowledge to implement, manage, and audit design and development activities with confidence. Whether you are new to design controls or seeking a structured refresher, this course will help you interpret the requirements and apply them in real-world scenarios.

Guided by experienced instructors, you will cover each stage of the design and development process:

  • Developing design plans and choosing methodologies
  • Defining and managing design inputs and outputs
  • Conducting effective design reviews
  • Performing verification and validation activities
  • Managing design transfer, changes, and technical documentation
  • Applying risk management and usability principles throughout the lifecycle

This training emphasizes practical application over theory. Through hands-on activities, case studies, and interactive discussions, you will build the skills needed to integrate design controls into your Quality Management System and prepare for audits and regulatory inspections.

Delivered in a live, instructor-led format, this course offers an engaging and flexible way to strengthen your design and development expertise without stepping away from your day-to-day responsibilities.

Pre-Requisites

Our goal is to meet everyone at their current level and increase it.

Medical Device students should review the ISO 13485:2016 Standard Clause 7.3 and 21 CFR 820.30 to prepare for class.

General Manufacturing students should review ISO 9001:2015 Clause 8.3 to prepare for class.

By reviewing these materials before class, you will come in aware of the content of the standards and be ready to learn how to apply them.
Design Control - Two people looking at a piece of paper with designs and making notes

Who Should Attend

  • Quality Managers/Engineers
  • Person Responsible for Regulatory Compliance (PRRC)
  • Regulatory Affairs Managers
  • Procurement Managers
  • Design Engineers
  • Process Engineers

 

Design Control Training Objectives

  1. Understand the regulatory basis of Design & Development (ISO 9001, ISO 13485, FDA QMSR, EU MDR).
  2. Learn the key elements of Design & Development: planning, inputs, outputs, reviews, verification, validation, transfer, and changes.
  3. Practice applying risk management (ISO 14971, ISO 31000) and GSPR (EU MDR Annex I) requirements to design activities.
  4. Gain tools for preparing compliant Medical Device File (MDF) and Technical Documentation.
  5. Develop strategies to integrate Design & Development within the Quality Management System.

 

Agenda

Part 1: Introduction & Course Overview
Welcome, expectations, introductions
Why Design & Development are critical (case examples)
 
Part 2: Medical Device Lifecycle & Regulatory Context
Device lifecycle under ISO 13485, FDA, EU MDR
Where Design & Development fit within R&D and product realization
 
Part 3: Design Planning & Methodology
Design planning requirements (ISO 9001 Clause 8.3 & ISO 13485 §7.3.2, 21 CFR 820.30(b))
Choosing a methodology: Waterfall, Agile, Lean, Concurrent Engineering
Activity: Drafting a Design & Development Plan
 
Part 4: Design Inputs & Outputs
Sources of input: User needs, regulatory, risk, usability
Outputs: Specifications, acceptance criteria, BOMs, Device Master Records/Medical Device
Activity: Review of design input/output checklists
 
Part 5: Design Reviews
Formal review requirements and documentation
Cross-functional participation and recordkeeping
 
Part 6: Design Verification & Validation
Verification vs Validation: Key differences and methods
Case studies and practical examples
Activity: Review and critique a verification/validation example
 
Part 7: Design Transfer & Change Control
Requirements for DHF, Technical Documentation, Device Master Record
Handling design transfer and post-market changes
GSPR Annex I checklist integration
 
Part 8: Risk Management, Usability & Human Factors
ISO 14971: Risk management throughout lifecycle
Integrating usability (IEC 62366) and human factors into design
Activity: Apply risk controls to design case study
 
Part 9: Wrap-Up & Next Steps
Review of learning objectives
Q&A session
Preparing your organization for audits and inspections

 

Related Courses 

ISO 13485 Lead Auditor Training ISO 9001 Lead Auditor Training Root Cause Analysis & CAPA Training EU Medical Device Regulation (EU MDR) Training

 

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