Combination Products and Regulations: a Risk-Based Approach

Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and recommendations from 21 CFR Part 4, and TIRs 48 and 105, as well as gain familiarity with interpretations within the emerging global marketplace.

Upcoming Virtual Courses


Combination Products: A Risk-Based Approach (June 2024)

Jun 4 to Jun 7, 2024


Combination Products: A Risk-Based Approach (Sep 2024)

Sep 3 to Sep 6, 2024


This 6-part virtual training provides an in-depth examination of the FDA’s approach to the regulation of combination products, including a review of the most current guidances and their interpretations, as well as an overview of the alignments and differences with the EU MDR's guidance.

Learn to identify how different countries and regions interpret what a combination product is and how those interpretations may impact the lifecycle of a combination product. The instructor will also guide you through processes to streamline and integrate the development of single entity, co-packaged and cross-labeled products. Discussion will also cover various approaches to aligning requirements to meet the regulations for the primary mode of action of a combination product.

The instructor will address FDA’s risk-based approach to combination products, including the called-out provisions in 21 CFR Part 4. The course will review how to meet the cGMP requirements commensurate with the risk of the product, integrating both risk and quality system management concepts. Relevant human factors processes will also be discussed in relation to the interface of the combination product, essential performance requirements, as well as post-marketing safety reporting considerations.


After participating in this session, the learner will be able to:
  • understand key terminology and interpretations associated with combination products
  • understand the FDA’s primary mode of action designation process
  • understand differences in global interpretation
  • understand the risk management framework for combination products
  • review key called out provisions relative to applicable cGMP expectations

What to expect

Module 1: Introduction to Combination Products

  • Introduction to Medical Products and Combination Products
  • What is a Combination Product?: A Global Perspective
  • Key Terminology Dictionary & Thesaurus

Module 2: Combination Products cGMPs: A Risk Based Approach

  • Combination Products Lifecycle: Risk Management Underpinning
  • Combination Product Regulations & Guidance
  • Quality System Expectations and cGMPs
  • Quality System Expectations and cGMPs

Module 3: Combination Products Integrated Development

  • Drug Development: QbD
  • Device Development and Design Controls
  • Purchasing Controls in the Combination Products Space
  • Combination Product Integrated Development- What’s Unique and Challenges to Overcome
  • SaMD and Combination Products

Module 4: Combination Products Risk Management

  • ICH Q9, ISO 14971 & AAMI TIR 105
  • Essential Performance Requirements (EPRs)
  • Combination Products Human Factors
  • Reliability

Module 5: Combination Products Lifecycle Management

  • Post Marketing considerations for Combination Products
  • Manufacturing, Supplier Quality, and Post Marketing Safety Reporting

Module 6: Combination Products Inspection Readiness

  • Review of FDA Combination Products Compliance Program for CDER- and CDRH-led Combination Products.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email


susan neadle

Susan Neadle

Susan is Principal Consultant/ Owner of Combination Products Consulting Services, LLC. She has over 30 years of experience in the medical device/pharmaceutical/biotechnology industry. Susan partners with industry, applying her extensive Design-to-Value, Design & Process Excellence and Program Management skills, coupled with her combination products, medical devices, IVD and digital health expertise, to enhance the effectiveness, efficiency and consistency of medical product lifecycle management from development, submission and review through post market, in a dynamic global regulatory environment. She holds numerous patents and publications, and frequently speaks in public venues.