Design reviews are a mandatory part of medical device development and are often mistakenly treated as a compliance checkbox. When done properly, however, they can become a meaningful competitive advantage. This article explains why medical device design reviews matter and how to conduct them effectively—from what a design review is and who should be involved, to the review process itself and the common pitfalls to avoid.

Medical Device Design Review in a Nutshell

A design review is a formal, documented, system-level evaluation of a medical device’s design and development outcomes.
It assesses whether the results meet the established requirements and serves as a checkpoint to confirm the design is progressing as planned and remains safe and effective for its intended use.

Why Design Reviews are More Important Than You Think

Design reviews are critically important for two reasons: one official, and one unofficial—but very valuable.

First, the Non-Negotiable Reality: They’re Mandatory

Market submissions to the FDA, Health Canada, and other regulatory bodies require medical device manufacturers to conduct formal design reviews. This is not optional; it is a fundamental requirement for building a device that can be legally marketed.

• FDA: The FDA explicitly requires formal design reviews under regulation 21 CFR 820.30. This mandate is enforced through systematic inspections and has serious consequences for non-compliance.
• ISO 13485: This international standard for medical device quality management systems outlines the requirement in Clause 7.3.5, Design and development review. Compliance is enforced through a system of third-party certification, which is essential for market access in many regions.

Because of this regulatory pressure, design reviews are often viewed as just another box to check on a long list of procedural requirements. However, the most successful development teams use design reviews for far more than compliance—they treat them as powerful drivers of project success.

The practical benefits: building a better device

When done effectively, medical device design reviews deliver tangible benefits that improve both the development process and the final product. In fact, they can become a team’s competitive advantage by providing:

• Better project management: Design reviews keep development on track and ensure the entire team is aligned on progress, priorities, and unresolved issues.
• Enhanced collaboration & improvement: They create a structured opportunity for cross-functional teams to provide constructive feedback, drawing on diverse expertise to strengthen the design.
• Risk mitigation: Reviewing the design at key milestones helps teams catch issues early—before they become deeply embedded and expensive to fix. Resolving a flaw in a meeting is far cheaper and faster than correcting it after tooling is cut or prototypes are built.
• Increase stakeholder confidence: For both internal leadership and external clients, a rigorous design review process provides visible proof of progress. It shows the device is on a clear, controlled path to market, building trust and confidence in the project’s success.

That said, this process is only as effective as the team assembled to execute it.

Who Should Be Involved in a Design Review

A successful design review depends on having the right mix of expertise and perspectives in the room. A well-rounded team enables a thorough, objective evaluation of the device design. Key participants typically include:

• Cross-functional representatives: Team members from all relevant functions involved in the design stage being reviewed, including participants from both the development firm and the client.
• The independent reviewer: An objective individual who is not directly involved in the design stage being reviewed, providing an unbiased perspective as required by the FDA. This reviewer may come from the development firm, the client organization, or an external advisory role.
• Specialists: Subject matter experts brought in for their specific knowledge of certain aspects of the device, as needed. This is often a representative from the client team.

Once the appropriate stakeholders are identified, the focus shifts to a disciplined, three-phase process designed to maximize efficiency and impact.

The Design Review Process: a Three-Phase Approach

A medical device design review is not a single meeting—it is a structured process designed to ensure discussions are productive and that identified issues are formally resolved. This three-phase approach prevents reviews from becoming aimless conversations and ensures insights lead to concrete actions.

How Often Should You Have a Design Review?

Design reviews should be scheduled in alignment with major project milestones—typically at the end of each design phase, or when necessary within a phase (eg,  pre- and post-prototype release). The rationale behind this cadence is simple: each design review serves as a formal “checkpoint” to confirm that the design meets its requirements before the team commits resources to the next stage of development. This ensures that the project is progressing according to plan and that the device remains safe and effective at every critical juncture.

Where Medical Device Design Reviews Go Wrong — and How to Correct Them

Ultimately, the goal is to move beyond compliance to use design reviews as a practical tool for building safer, more effective devices. To achieve this, it’s helpful to remember not just what to do, but what to avoid.
Below are the most critical mistakes to watch for when planning and conducting design reviews:

Key Takeaways for an Effective Design Review

The ultimate goal of the design review process is not merely to satisfy regulators, but to use it as a proactive, collaborative tool for building safer and more effective medical devices. Mastery of this process is a hallmark of a high-performing development team.

Here are the most critical principles to remember:

• The goal: Move beyond simple compliance to use reviews as a powerful tool for genuine device improvement and risk mitigation.
• The people: Always assemble a cross-functional team that includes an independent reviewer and specialists to ensure a comprehensive and objective evaluation.
• The process: Be prepared, manage time well, and conduct frequent, focused reviews with a narrow scope rather than infrequent, oversized ones.
• The follow-up: Ensure every action item is tracked until it is formally documented as closed. A review is not complete until its findings are resolved.