Welcome & Course Overview

• In this lesson, you’ll get an overview of the course, learn who this training is designed for, and understand the key topics you’ll explore throughout the program.
  
  

 About Ventura Solutions

• In this lesson, you’ll learn about Ventura Solutions, its mission, and how the company supports medical device and combination product organizations through consulting, staffing, and training solutions.
  
  

Instructor Background (Chuck Ventura) and Why He Created This Course

• In this lesson, you’ll gain insight into Chuck Ventura’s background, his experience in medical devices and combination products, and why he created this course on design controls and risk management.

Bridging Device & Pharma Approaches — ICH Q8/Q9/Q10 vs Device Design Controls

• In this lesson, you’ll learn how pharmaceutical ICH frameworks relate to medical device Design Controls and how these approaches align within combination product development.

What Are Combination Products?

• In this lesson, you’ll learn what combination products are, review common examples, and understand their growing importance.

Key Definitions: Drug, Device, Biologic

• In this lesson, you’ll build a foundation in key regulatory terms to support clear understanding and communication.
  
  

Regulatory Framework Overview (CFR, QMSR, ISO) and PMOA

• In this lesson, you’ll learn the basics of key regulatory frameworks and how PMOA influences the regulatory pathway for combination products.

The Role of Quality Systems (ICH / ISO 13485) and CFR Part 4

• In this lesson, you’ll understand how quality systems guide development and ensure compliance.

Overview of the FDA’s QMSR Update and Changes to Design Controls (21 CFR 820.30)

• In this lesson, you’ll learn the basics of the FDA’s QMSR update, understand key changes to Design Controls, and see how the regulation aligns with ISO 13485.

• In this lesson, you’ll see how design outputs are used in manufacturing, quality, and day-to-day operations.

Manufacturing & Design Transfer

• In this lesson, you’ll learn how development activities and design outputs are translated into real manufacturing processes.

Supply Chain & Purchasing Controls

• In this lesson, you’ll learn why supplier management and purchasing controls are critical to maintaining product quality and performance.

Quality Control & Inspection Strategy

• In this lesson, you’ll learn how inspection and testing strategies help ensure product consistency and how they connect to design and risk management activities

Overview of Design & Development Process

• In this lesson, you’ll learn about the design control process and understand how each stage fits together throughout product development.  

The Design and Development Plan

• In this lesson, you’ll learn about the Design and Development Plan and its role in organizing development activities and deliverables

Design Inputs

• In this lesson, you’ll learn what Design Inputs are and the role they play in product development.

Design Input Example

• In this lesson, you’ll see a real-world example of how user needs are translated into clear, measurable design inputs.

Design Outputs

• In this lesson, you’ll learn what Design Outputs are and how they support manufacturing, testing, and product quality. 

    

Design Reviews

•  In this lesson, you’ll learn why design reviews are important, how they support product development, and their role in regulatory compliance.

Pre-V&V (Early Characterization)

• In this lesson, you’ll learn what Pre-V&V is, why it is important, and how early characterization activities help identify issues sooner and reduce development risk.

Design Verification

• In this lesson, you’ll learn what design verification is and how it demonstrates that design outputs meet design input requirements.

Design Validation

• In this lesson, you’ll learn what design validation is and how it confirms the final product meets user needs and intended use.

Design Transfer to Manufacturing

• In this lesson, you’ll learn what design transfer is and how design outputs are translated into manufacturing processes and production specifications

Change Control Fundamentals

• In this lesson, you’ll learn what change control is and how it helps ensure product changes are properly evaluated, documented, and implemented.

Design Files (DHF / DDF)

• In this lesson, you’ll learn about the Design and Development File (DDF/DHF) and its role in documenting product development and supporting regulatory compliance.

Purchasing Controls

• In this lesson, you’ll learn how purchasing controls help manage suppliers and protect product quality, safety, and performance.

Complaint Handling, Analysis of Data & Improvement

• In this lesson, you’ll learn how complaint handling, data analysis, and post-market activities support product monitoring and continuous improvement.

Device Add Ons

• In this lesson, you’ll review the device “add-on” requirements under 21 CFR Part 4 for combination products.

Case Study — Developing a Design Input Specification

• In this lesson, you’ll walk through a real-world case study demonstrating how design input specifications are developed using a risk-based and user-focused approach.

Design and Development Summary

• In this lesson, you’ll review the key concepts covered throughout the Design and Development section.

Device Development Roadmap Overview and Cross Functional Team

• In this lesson, you’ll get a high-level overview of the device development roadmap and learn about the cross-functional teams and expertise required throughout product development.

Device and Pharma Integrated Product Development

• In this lesson, you’ll learn how pharmaceutical and medical device development activities are integrated within combination product development, including the differences between clinical-stage and commercial-stage development.

Device Development Roadmap Phases

• In this lesson, you’ll learn the different phases of product development, including feasibility, clinical, and commercial development, along with typical timelines associated with each stage.

Device Development RACI 

• In this lesson, you’ll learn how responsibilities are assigned across cross-functional teams during product development using a RACI framework, and how different functions collaborate throughout design, risk management, verification, validation, and design transfer activities.

Introduction to Risk Management

• In this lesson, you’ll learn the fundamentals of risk management, including ISO 14971, its integration into the quality system, and the key elements of an effective risk management framework.

Management Responsibilities and Personnel Competency

• In this lesson, you’ll learn about management responsibility and personnel competency requirements within a quality management system.

The Risk Management File

• In this lesson, you’ll learn what documents and deliverables are included in a risk management file and how it connects to other design and quality system records.

The Risk Management Plan

• In this lesson, you’ll learn what a risk management plan is, why it is important, and the key elements it should contain.

Risk Analysis Fundamentals

• In this lesson, you’ll learn how hazards, hazardous situations, harms, and probabilities are used to identify and analyze product risks.

FMEA & Failure Mode Analysis

• In this lesson, you’ll learn how FMEAs and failure mode analysis are used to identify potential failures and support product risk analysis.

Risk Calculation & Evaluation

• In this lesson, you’ll learn how severity and probability are used to calculate risk and how risk acceptability is evaluated

Risk Controls & Residual Risk

• In this lesson, you’ll learn how risk controls are implemented and evaluated to reduce residual risk to acceptable levels.

Case Study on Risk Controls

• In this lesson, you’ll review a real-world case study showing how implementing risk controls can sometimes introduce new risks that must also be evaluated.

Benefit-Risk Analysis

• In this lesson, you’ll learn what a benefit-risk analysis is and gain a high-level understanding of how it is performed.

Risk Management Report and Post-Market Requirements

• In this lesson, you’ll learn how risk management activities are documented and maintained throughout the product lifecycle, including post-market monitoring activities.

Risk Management Summary

• In this lesson, you’ll review the key concepts covered throughout the Risk Management section.

Course Recap & Key Takeaways

• In this lesson, you’ll review the key concepts covered throughout the course and reinforce how design controls, risk management, quality systems, and product development activities work together.

Final Message & Closing

• In this lesson, you’ll receive final guidance on applying the concepts learned throughout the course and continuing your development within the medical device and combination product industry.