Defining a strategy for design history file remediation

When pharmaceutical companies launch a new product, often it is a combination of a new drug in an existing, proven delivery device. Because all new pharma products have full regulatory scrutiny, it is important to make sure the medical device design history file (DHF) is up to date and meets the latest standards.

DHFs can become surprisingly complex documents because they may have been through long-running development programmes incorporating many changes or they may have been acquired from other companies and contain significant legacy elements. Sometimes the passage of time has meant a DHF is no longer of the standard needed to pass FDA audit so it presents a business risk.

In any of these cases, factors such as new standards and regulations or changes in intended use, risk profiles or manufacturing processes make it important to defining an appropriate strategy to upgrade the DHF at the outset.

There are several aspects central to defining an effective strategy – such as building a detailed narrative, using a suitable quality management system (QMS) framework and effective planning.

A design story

Central to the concept of generating a robust DHF is the aspect that should frame the mindset of both development and remediation projects – to create a narrative, or history, of the development journey. The goal should ideally be not to create a clean set of ‘Revision A’ documents but to use and develop the tools of an efficient quality system to create a narrative of the complete development process. This is, most importantly, about creating visibility of all the technical decisions, learnings and changes along the way but can include broader aspects such as changes of ownership, changes to major standards or evolution of the supporting quality systems. Creating a narrative can be more challenging in remediation projects but employing the right philosophy can create opportunities to simplify a complex challenge.

Fit for purpose

The two key elements of the DHF generation are the specific technical content and the quality system framework used to collate and describe the format of the file.

It’s critical to define early on what success looks like for the revised DHF and understand the strategic decisions that need to be made to facilitate creating a robust file. 

Remediation projects are usually not an ideal time to implement a comprehensive change to QMS processes in parallel, however appealing that may seem, so a best-practice approach leveraging existing processes is usually a sound strategy.

It is, of course, vital to check that the resulting DHF complies with the current guidance of key standards such as ISO13485 and FDA 21 CFR Part 820. In cases where a comprehensive QMS framework is not available, it is important to use other tools – such as a fully detailed quality or development plan – to describe approaches and adaptations to be employed to create a robust DHF.


With these two key aspects in mind, the planning activities can then be focused on establishing the framework and resources required to move forward.

A fully detailed project plan will describe all the tasks to be delivered but is also vital to ensure any relevant experts and stakeholders are in place and available when required. The early planning of workshops and stage-gate reviews is very important to ensure smooth progress.

An effective and fully detailed quality plan with scope, objectives and a clear set of deliverables will greatly help to get alignment on the specific goals with all relevant stakeholders and help to assess the skills and resources needed.

Employing an effective stage-gate process is a great way to monitor progress and assess the status as the project progresses. Communication and stakeholder engagement are vital to progressing effectively so using stage-gate meetings to record open actions, assess risks and assign tasks gives visibility of issues and allows detailed planning.

A successful remediation project depends on many elements – but a robust strategy, expert resources and effective communication are vital aspects that will certainly reward additional investment.

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Carl Pullen

Senior Consultant Mechanical Engineer