Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

Overview:

Design flaws — not manufacturing errors — continue to be the leading cause of medical device recalls, a fact that has shaped how regulatory bodies like the FDA approach compliance. Through in-depth analyses of adverse events and product failures, the FDA has determined that inadequate design control processes often allow critical risks to go unidentified until it’s too late. As a result, device manufacturers are expected to implement structured, risk-based design programs that systematically anticipate, track, and mitigate potential hazards from the earliest stages of development.

The push for harmonization has only intensified. In 2024, the FDA finalized its alignment with ISO 13485:2016, signaling a shift toward globalized quality expectations. For manufacturers, this means their design processes must now meet both domestic and international standards — a transition that has caught many companies off-guard. Organizations with legacy systems often find themselves struggling to interpret the newer requirements, especially when it comes to integrating quality, usability, and safety within a single design lifecycle.

Compounding the challenge is the ambiguity surrounding when design control should formally begin. Some companies initiate too late, after foundational decisions have been made and documented informally. Others start too early, burning out their teams with unnecessary paperwork and bottlenecks. This lack of clarity continues to create friction between development teams, regulatory affairs, and executive leadership, particularly in fast-paced environments where speed to market is a top priority.

Another ongoing challenge is managing change. The distinction between pre-release and post-release change control is often misunderstood, leading to inconsistent documentation and compliance risks. As product development becomes increasingly iterative — especially in digital health and software-driven devices — clear, compliant change control processes are essential yet frequently neglected. Similarly, Human Factors Engineering remains underutilized, even as the FDA tightens expectations around usability. Missteps in this area can lead to products that pass technical validation but fail in clinical or home-use settings.

Equally important is the Design History File (DHF), which is more than a regulatory checkbox — it serves as the definitive record of how risk, design decisions, reviews, and validations were handled throughout the product lifecycle. However, many organizations still treat it as a document repository rather than a strategic compliance tool. Misalignment here can lead to audit failures or, worse, real-world safety issues.

Lastly, a pervasive misconception persists around validation. Many teams equate validation with testing, missing its broader scope. True validation demands a thorough demonstration that the final product fulfills user needs, performs safely and effectively in its intended environment, and reflects risk mitigation across all design stages. This is particularly vital in hardware-software integrated systems, where a testing-only approach cannot guarantee safe system behavior under diverse use conditions.

This webinar will bring all these elements into focus, offering professionals a structured understanding of what risk-based design control entails under current FDA and ISO expectations, how to avoid critical process gaps, and how to build a defensible, compliant design control system that holds up under scrutiny.

Areas covered in the session:

• Reasons for design control
• When design control begins
• Elements of a design control program
• How risk management fits into design control
• Change control
• Understanding  validation (consists of  more than testing)
• Design History File

Why should you attend?

If you're involved in medical device development, quality assurance, or regulatory affairs, you already know that the stakes are high — and the rules are getting stricter. The FDA’s increasing emphasis on risk-based design control and its alignment with ISO standards means that even experienced professionals are being challenged to rethink traditional development strategies. This session offers clarity in a space where ambiguity often leads to costly mistakes.

Many professionals still grapple with when and how to properly initiate design control, how to handle frequent product changes without breaking compliance, and how to document risk in a way that stands up during an audit. This training tackles these common pain points head-on, using real-world scenarios and regulatory expectations to ground your understanding.

Whether you're launching a new product or refining an existing design process, this webinar will equip you with the context, insight, and practical guidance needed to strengthen your approach.

Handouts are pre release change control form, post release change control form, user requirements template, DHF checklist

Who will benefit?

This webinar is designed for professionals involved in the design, development, regulatory compliance, and quality assurance of medical devices — those include:

• Design Engineers
• R&D Managers
• Quality Assurance Managers
• Regulatory Affairs Specialists
• Product Development Teams
• Risk Management Professionals
• Design Control Coordinators
• Compliance Officers
• Validation Engineers
• Human Factors Specialists
• Documentation Specialists
• Project Managers in Medical Device Development
• Software and Systems Engineers working on medical devices
• CAPA Managers
• Manufacturing Engineers involved in product lifecycle
• Consultants supporting FDA and ISO 13485 compliance
• Internal Auditors and QA/QC Analysts
• Medical Device Start-up Founders and CTOs