How to Manage Technical Changes in MedTech: Design & Process Changes
In the fast-moving world of medical devices, change is inevitable, whether it’s a tweak to a component, a new manufacturing method, or an adjustment to software or equipment. But while innovation drives progress, each technical change also introduces potential risks, and can affect many other documents. Even a small modification can trigger a chain reaction across your quality system, manufacturing operations, suppliers, and regulatory filings.
“Technical changes are rarely isolated,” explains Axel Strombergsson, VP at QuickVault by Veeva. “A small design change can cascade into affecting testing, packaging, or even products in the field. What looks like a minor update can quickly turn into a 6-month full-blown project that affects your entire organization.”
Managing technical changes efficiently and in compliance with FDA and ISO expectations requires the right balance of control and agility. This article explains how MedTech companies can navigate that balance through structured processes, cross-functional collaboration, and modern digital tools.
What “Technical Change” Really Means
A “technical change” in MedTech can refer to almost any modification that affects the design, materials, manufacturing process, or equipment used in developing or producing a device. During early research and feasibility work, teams can iterate freely as MedTech regulations do not apply to the same extent as following design freeze. But once the formal design of the device begins, following the Design Control Regulations under 21 CFR 820.30 / ISO 13484, every change, no matter how small, falls under regulatory oversight.
This means that any update impacting a device’s design, performance, safety, or compliance must be formally documented, reviewed, and approved. Changes to the design history file (now the Medical Device File under FDA’s new Quality Management System Regulation) must also be assessed from a risk and regulatory perspective.
According to Axel, “From the point formal development starts, change control applies. That extends to your design, manufacturing processes, and even equipment used for manufacture of the device”.
The Cascading Effect of Changes
In theory, technical changes can range from minor adjustments to complex, multi-month undertakings. In practice, even small changes can ripple through your system.
Consider a seemingly simple change, say a small change to the diameter of a small circular part within the device. That one small update might alter how parts fit together, affect assembly methods, or even require re-testing to ensure the device is still effective and safe for its intended use. In certain cases, the change can even impact regulatory approvals such as a CE mark or a 510(k) clearance.
“Changes often have a cascading effect,” Axel notes. “It’s not just about updating one drawing. You might have to update work instructions, redo validation of a manufacturing process, revise supplier documentation, and retest the device to show continued safety and efficacy.”
Beyond the technical and regulatory implications, there’s also an operational and general business burden. A minor tweak may still require large amounts of resources (people, time, money), cross-functional participation, project planning, and risk reassessment, consuming time and resources that can stall innovation and slow down business growth if not well managed.
Planning Technical Changes Without Slowing Innovation
Every technical change, whether minor or complex, should be defined, scoped, and treated like a project. That begins with an initial scope of the change, basically a cross-functional review of the impact of the change and any cascading effect, as well as resource and time planning.
Technical changes must be managed through an Engineering Change Order (ECO), a best-practice framework that details the scope of the change, how it affects other areas of the business and QMS, and also ensures transparency, accountability, and alignment before execution.
An ECO typically outlines:
- The rationale for the change (why it’s needed and what issue it addresses)
- The potential impact on design, testing, processes, or regulatory documentation
- Resources and timelines required to complete the work
- Cross-functional review and approval across R&D, Quality, Regulatory, and Operations
For MedTech companies, this upfront planning is what drastically reduces risk and enables speed without sacrificing compliance. Too often, teams rush change and subsequent implementation, and thereby risk downstream non-conformities, rework, and delayed product distribution. Axel emphasizes that the balance between agility and rigor depends on strong project management and leadership prioritization.
“Don’t skip the planning phase,” he advises. “A well-defined change order prevents missteps later. And when leadership recognizes the business importance of technical changes, especially those tied to quality issues and product availability, it helps teams prioritize and move faster with confidence.”
Modern tools make this balance achievable. With an eQMS like QuickVault, teams can initiate and track ECOs, assign responsibilities and tasks, and route reviews automatically. Document updates cascade across connected records in the Medical Device File, ensuring full traceability without the manual overhead. The result is higher transparency of change impact, faster execution, stronger control, and significant reduction of the risk of running into unforeseen issues.
Making the Change and Risk Management Connection
Every technical change shall include a review of the device’s risk management file. This ensures that any new risks introduced, or changes to existing ones, are identified, evaluated, and mitigated.
If a change increases a known risk or introduces a new one, that must be captured and mitigated. Reviewing your risk assessment helps determine whether additional testing or design updates are needed.
For example, if a design modification could affect biocompatibility, usability, or sterilization, the risk assessment should inform the verification and validation plan as part of the change project. This not only supports compliance but also helps teams prioritize change and testing efforts strategically.
The Evolution of Design and Process Changes
During early design and development, changes are typically design-driven to address functionality, safety, or usability. Once a product reaches market, the focus shifts.
“Post-commercially, design changes should taper off, as extensive testing of the device is done prior to commercialization,” Axel explains. “But as you scale production, process issues and changes become much more common, whether due to supplier chain performance, manufacturing capacity constraints, or simply manufacturing equipment wearing out”.
Process changes can be very complex and lengthy, especially when working with contract manufacturers. Updates to tooling, assembly lines, or supplier materials may require process re-validation (IQ/OQ/PQ) and third-party coordination and training.
The key is to evaluate each change’s impact on validation status and regulatory compliance. Even if the design itself remains unchanged, the process output must still meet specifications and output performance requirements.
Technical Changes Necessitate Cross-Functional Collaboration & Traceability
Technical changes touch nearly every function, including Engineering, Manufacturing, Quality, Regulatory, Supply Chain, and sometimes Sales. The only way to prevent gaps or rework is through proactive alignment.
“A technical change should always be treated as a project,” Axel says. “Plan it, assign resources, and get a cross-functional team involved up front.”
Setting up recurring cross-functional project meetings early ensures the right people are involved to ensure project buy-in, and to assess any ripple effects the change may have on suppliers, products in final goods inventory, or in the field.
A best practice is to structure recurring project meetings (weekly or biweekly) where stakeholders can review progress, address issues, and maintain visibility. This not only strengthens compliance but also minimizes disruption to production and distribution.
This will also help you avoid communication breakdowns, one of the most common causes of project failure. Without this cross-functional collaboration, R&D teams may update drawings or process instructions without properly informing downstream stakeholders, or worse, fail to link updates back to risk or design documentation.
That’s why digital traceability is essential. With QuickVault, teams can easily see how one change affects connected items such as specifications, work instructions, and supplier documents.
“Being able to click into a specification and immediately see what it’s tied to, like other documents, suppliers, equipment, provides transparency that helps you avoid missing something critical that is affected by the change,” Axel notes.
Evolving Regulatory Expectations for Change Control
Change control isn’t just about reacting to issues; it’s becoming increasingly proactive. The FDA’s introduction of Predetermined Change Control Plans (PCCPs) encourages companies to identify and describe how they’ll manage foreseeable post-market changes as part of the initial submission.
While this approach is still developing, it reflects a broader regulatory shift toward lifecycle management. As Axel explains, “Companies now have to think ahead, predicting future changes and building systems that can handle them efficiently.”
In parallel, both FDA and ISO are emphasizing continuous improvement and data-driven decision-making. That means companies must be prepared to demonstrate not only that they followed change-control procedures but also that they used those processes to enhance device safety and performance over time.
Managing Technical Changes with Confidence
Technical changes are an unavoidable, and often beneficial, part of every MedTech company’s journey. But without structure, visibility, and proactive collaboration, even small adjustments can spiral into costly setbacks.
MedTech companies that handle change best are those that treat it as a strategic capability. They plan deliberately, involve the right experts, and use connected tools to maintain compliance and efficiency from concept through commercialization.
QuickVault by Veeva empowers MedTech teams to manage change seamlessly, linking design, quality, and regulatory activities in one unified system. With automated documentation, real-time traceability, and built-in change-control workflows, QuickVault helps your team move faster, reduce risk, and keep your devices market-ready. See how by trying QuickVault today →
