Designing a Test Plan that Works Globally: A Medtech Makers Q&A

As regional variations can create inconsistencies for testing a device, it’s important to work with a vendor that understands and can accommodate those differences.

By Sean Fenske, Editor-in-Chief, Medical Product Outsourcing

 

Medical devices are developed with at least one universal primary goal—to help patients. That can involve treatment, diagnosis, prevention, or recovery. As such, it’s vital a device is determined to be safe and effective in accomplishing its task. Regardless of clinical application, the device needs to perform as intended under all potential conditions.

 

To ensure this, a test plan is developed that is specific and customized to each medical device. The test plan must take into consideration how and where a device will be used, how it will be transported to that location, potential compatibility issues with the surrounding environment, who will use the device, and other important factors. All of this helps steer the test plan design.

 

Given the varying requirements for medical device testing around the world, representatives from Nelson Labs and Regulatory Compliance Associates (RCA) responded to a number of questions on the topic. In the following Q&A, Audrey Turley, RM (NRCM), CBA (ASQ), Biosafety Segment Leader, and Thor Rollins, RM (NRCM), VP, Global Market Segment Leader—Medical from Nelson Labs, joined Jordan Elder, RAC, Director of Regulatory Affairs at RCA, to provide the following comprehensive overview.

 

Sean Fenske: When it comes to medical device development, what is a test plan? What does it entail?

Audrey Turley: Test plans are developed for multiple scientific areas regarding medical devices. Test plans specifically for biocompatibility, or biological safety, should be compliant with the most current revision of ISO 10993-1. These test plans are commonly referred to as a biological evaluation plan, or BEP. Additional consideration for the market of submission should also be included, as each regulatory agency can have further requirements for specific medical devices.

 

Jordan Elder: Just to expand on what Audrey said, a test plan is commonly referred to as a verification and validation plan. It is a core document that defines how manufacturers will demonstrate their device is safe and effective and meets applicable regulatory and design requirements. It acts as a bridge between the design inputs and the design outputs. The test plan is intended to identify all verification and validation activities required to support regulatory submissions. The test plan maps the design requirements, performance specifications, and applicable standards to each specific test method, acceptance criteria, sample size, and rationale. The test plan also defines the samples and justifies that they are production equivalent. The test plan ensures that no critical requirements are overlooked during testing.

 

A typical testing plan should include (or consider including) functional and performance testing, biocompatibility evaluations, sterilization validation (if applicable), packaging and shelf-life testing, electromagnetic compatibility (EMC) and electrical safety testing, usability/human factors testing, environmental and transport stability testing, and software verification and validation (if applicable). This test plan is a part of the design control framework within the QMS and typically feeds into the risk management process (ISO 14971). The plan must be reviewed and approved, and it should be traceable back to the design and development plan.

 

Thor Rollins: As Jordan mentioned, the test plan is the strategic roadmap for generating the evidence needed to demonstrate a medical device is safe, effective, and fit for its intended use. It is more than a list of required tests. A good test plan links the device design, materials, manufacturing process, clinical application, and regulatory pathway to the specific data needed to support development and market access.

 

In practice, a test plan typically outlines what needs to be evaluated, why it needs to be evaluated, what standards or regulatory expectations apply, when the work should be performed, and how the results will be used. Depending on the device, this can include biocompatibility, sterilization validation, packaging validation, shelf life, chemical characterization, microbiology, functional performance, and other product-specific evaluations. The best test plans are risk-based, intentional, and built early enough to prevent costly surprises later in development.

 

Fenske: What defines what must be in the test plan? What effect does the type of device or clinical application have on the test plan?

Turley: ISO 10993-1 outlines a risk management process to follow when writing a BEP. An initial part of a BEP is a full description of the device and how it is used. Pictures are extremely helpful in this section of the document to bring all readers to the same understanding, regardless of expertise with the specific device. For many regions, it is typical for medical devices to be classified based on their risk to the patient. However, from a biocompatibility perspective, devices are not classified but rather assessed for risk based on the type and duration on contact as every device has the potential to introduce risk to a patient.

 

Elder: In addition, the contents of a test plan are determined by the regulatory evidence required to demonstrate a device is safe and effective for its intended use. Typically, the design and development plan will dictate what must be in the test plan. The test plan should include how the risks associated with testing will be used to determine a statistically significant sample size, a justification for the samples to be used for testing, any additional requirements for external testing facilities, and the requirements for test method validation. The test plan should outline the workflow process in instances where samples are used for multiple tests and include a justification for the applicability of the devices used in these tests. The test plan should cover the entire process by which the device demonstrates verification evidence for all design input requirements.

 

Design inputs act as the foundation for all testing and verification activities. The design inputs are supplemented by applicable consensus standards, such as ISO 10993 for biocompatibility or IEC 60601-1 for electrical safety. Region-specific guidance documents provide further input requirements where applicable. The manufacturer’s risk management process also defines the scope of the testing plan by ensuring each risk control identified during the hazard assessment is mitigated and supported by objective evidence.

 

The type and intended use of the device will significantly impact the testing plan’s scope and complexity. For example, a low-risk, skin-contact device and a long-term, blood-contacting implantable device require very different testing strategies. Using these two examples, the biocompatibility requirements could range from basic cytotoxicity and sensitization studies to a testing strategy that includes chronic systemic toxicity, hemocompatibility, and implantation evaluations. The biocompatibility testing will ultimately depend on the nature and duration of the device’s intended body contact. Furthermore, software-driven devices require a full verification and validation testing lifecycle. Ultimately, the device classification, device contact characteristics, the intended patient population, and overall complexity of the device will all act together as primary drivers determining how extensive and rigorous the testing plan must be.

 

Rollins: So, in summary, what must be included in a test plan is driven by the totality of the device: its intended use, duration and nature of body contact, materials of construction, route of exposure, method of manufacture, sterilization modality, packaging system, and clinical context. Regulatory requirements and applicable consensus standards also play a major role, but they should be applied through the lens of device-specific risk.

 

The type of device and its clinical application can dramatically change the testing strategy. As Jordan’s examples demonstrated, a short-term externally communicating device will not require the same evidence package as a long-term implant, and a device used in a neurologic or cardiovascular application may warrant a different level of scrutiny than a simple skin-contacting product. Combination products, reprocessed devices, and devices with novel materials or manufacturing methods can add even more complexity. In other words, the test plan should never be “one size fits all.” It should reflect the actual biological, chemical, physical, and clinical risks of the device in question.

 

Fenske: If the device is going to be used in multiple regions around the world, how does that impact the test plan? Can a single test cover multiple requirements, or does each region have a slightly different aspect that requires additional testing?

Turley: The ISO 10993 standards are international, where each country translates and adopts its own version. It is often the case that countries adopt the ISO version without edits. However, each regulatory body has its own interpretation of the standard itself, meaning even when the words are translated, the standard is carried out or understood differently. For the U.S., the FDA publishes acceptance or rejection of standards on their consensus standards database. This helps companies understand where the FDA has different expectations for the standards.

 

Elder: Also, when a device is planned to be used in multiple regions, it is important to ensure manufacturers have a comprehensive regulatory strategy to identify requirements and prevent duplicative testing across regions. It is critical manufacturers map all applicable standards and regional regulatory requirements to build a master test plan that can capture everything in a single pass.

 

It is important to note harmonized testing standards are not always identical to the parent testing standard. For example, the FDA may have specific recognized standard editions or national deviations for EMC testing. At the same time, the EU MDR demands more rigorous clinical evidence and chemical characterization than most other markets. China’s NMPA typically requires a recognized in-country testing facility regardless of how good your data is.

 

Bench testing requirements often overlap significantly between regions; however, clinical evidence requirements, documentation, packaging, and labeling expectations can vary in ways that require additional consideration. Manufacturers should design their testing approach from a worst-case testing standpoint to help encompass multiple regional regulatory requirements. The manufacturers that navigate this most efficiently are the ones that treat multi-region strategies as a design input rather than a retrofitting exercise after the data has already been collected.

 

Rollins: To reiterate, global commercialization should influence the test plan from the beginning. In many cases, a well-designed study can support multiple markets, especially when internationally recognized standards are used, and the rationale is clearly documented. That is one of the major benefits of building a globally informed testing strategy early: it can reduce redundancy and improve efficiency.

 

That said, regional expectations are not always identical. While there is significant harmonization in many technical areas, regulators and notified bodies can still differ in how they interpret standards, the depth of justification they expect, or the type of supporting data they want to see. Sometimes the testing itself can be leveraged globally, but the documentation, risk rationale, or framing of the conclusions may need to be tailored for a specific region. Manufacturers should not assume that passing a test automatically means universal acceptance. The real goal is to generate data in a way that is technically sound and broadly usable.

 

Fenske: If a device is only being launched in one region, does it make sense to do additional testing for potential future commercial launches in other regions? Or does that become cost-prohibitive?

Turley: Manufacturers may decide to perform the testing required for all regions of submission at once or stagger the testing to push the costs down the road. It is important to have a strategy of submission to know all that will be required; however, the decision remains with the business side of the manufacturer.

 

Elder: Exactly. The answer will truly depend on the manufacturer’s commercial strategy and plans for the device in question. In most cases, companies that choose to incorporate the additional testing requirements upfront find that the testing is significantly more cost-effective than conducting a second study with the new requirements added to meet additional regulatory requirements. The cost of adding a few extra testing endpoints is typically small when bundled with an existing testing plan. When companies choose to test specific endpoints after testing is completed, it can cost significantly more, as the testing may require a complete retest to add the additional endpoints.

 

However, manufacturers should be cautious not to fall into the mindset of trying to satisfy every conceivable regulatory requirement across the global markets. Manufacturers should assess the cost-to-benefit for adding testing endpoints, as additional endpoints will increase costs and, likely, the overall test duration. I recommend manufacturers select critical markets where they may want to market their device in the future and test those requirements, rather than trying to test everything.

 

Rollins: As my colleagues have stated, in some cases, it makes sense to build a slightly broader evidence package up front if there is a realistic expectation of near-term expansion into other markets. Doing so can save time, conserve samples, and avoid repeating studies or explaining why earlier work was not designed with future requirements in mind.

 

However, there is a balance. Over-testing too early can consume budget and extend timelines without creating immediate value. The smartest approach is usually not to test everything possible, but to design the initial strategy so future expansion remains feasible. That means understanding where the likely global gaps are, preserving flexibility in study design, and avoiding narrow decisions that could limit future market access. It is less about doing every possible test today and more about ensuring today’s plan does not create tomorrow’s problem.

 

Fenske: When seeking a testing partner for a device that will launch in multiple regions, what should a device manufacturer seek in that partner? What criteria are important?

Elder: When considering a testing partner, manufacturers should look to companies that can offer multiple areas of testing, so they do not have to work with multiple organizations for each type of test or region.

 

Turley: Specifically, when designing a BEP, awareness of the differences for each region is critical; therefore, a partner with global experience is highly beneficial. Additionally, a partner that will fully support the data through the regulatory body is important for good technical conversations.

 

Rollins: In addition, manufacturers should look for a partner that offers more than test execution. For a global device program, the ideal testing partner understands the science, the regulatory landscape, and how the full evidence package fits together. They should be able to help the manufacturer build a testing strategy, not just quote individual studies.

 

Key criteria include technical depth, experience with the relevant device type, familiarity with global expectations, quality systems, regulatory credibility, and the ability to provide integrated support across disciplines. Responsiveness and transparency also matter greatly. If a partner is only answering the question asked, rather than helping the manufacturer see around corners, that is usually a missed opportunity.

 

Another important consideration is whether the testing partner can think holistically. Many delays and unnecessary costs come from disconnected testing decisions made in silos. A strong partner can help connect biological risk, chemistry, microbiology, sterilization, packaging, and product lifecycle considerations into a coherent plan that better supports regulatory success.

 

Fenske: What aspects or expectations with regard to device testing do you find to be overlooked, not considered, or misunderstood? Can you explain what should be kept in mind for these aspects of device testing?

Elder: One of the most overlooked aspects of design verification testing is the determination of the appropriate sample size for the specific device. The determination is based on the risk as well as the confidence and reliability intervals necessary for the specified risk under evaluation. The determination criteria should be outlined in the plan and based on the manufacturer’s 14971 risk management file. Another test manufacturers often overlook is transport and environmental testing. Manufacturers typically focus on a device’s performance and safety testing but fail to fully consider requirements from a transport and environmental perspective. Environmental factors such as humidity, vibration, drops, and altitude changes during transport can significantly impact a device’s integrity, ultimately impacting its safety and effectiveness. Manufacturers should fully evaluate these factors before the final stages of testing.

 

Additionally, shelf-life and aging studies tend to be overlooked as last-minute considerations, both because of the time required and because of what needs to be evaluated. Manufacturers must consider all aspects of shelf-life and aging, including packaging integrity, material degradation, battery performance, and adhesive stability (where applicable). Furthermore, manufacturers must conduct confirmatory functional testing of the device to ensure critical parameters are still met after completing certain tests, such as shelf-life and transport stability. Manufacturers should ensure functional testing is conducted at multiple points during the validation process to confirm the device meets its required performance specifications, regardless of environmental factors. Manufacturers with software should plan appropriately and incorporate cybersecurity into their design as early as possible. Many manufacturers fail to account for this requirement or wait too long, resulting in a much more difficult integration into the overall design, ultimately costing time and money to redesign the software architecture.

 

Usability and human factors testing are other areas that are often misunderstood. Many organizations, unfortunately, treat this testing requirement as a late-stage checkbox rather than a consideration to be included as part of the formative design. Manufacturers that fail to consider usability and human factors in the initial stages of development may find their summative study identifies fundamental use errors that could have been mitigated much earlier. These failures can lead to costly redesigns or risk-based justifications that reviewers may not find acceptable, ultimately delaying market clearance/approval of the device.

 

Rollins: To emphasize a common misunderstanding Jordan mentioned is the idea that device testing is simply a checklist exercise. In reality, a good testing strategy is fundamentally about risk management and scientific justification. Standards are critical, but they are not meant to replace thoughtful evaluation of the device itself.

 

Another frequently overlooked point is timing. Too often, manufacturers wait until late in development to think seriously about their test strategy, at which point design choices, material selections, manufacturing methods, or packaging decisions are already locked in. That can make the testing more expensive, more difficult to interpret, or misaligned with the final product.

 

I also see manufacturers underestimate the importance of chemistry, materials understanding, and manufacturing change control. A device is not just its intended design; it is the total product as manufactured. Small changes in suppliers, processing aids, residuals, packaging, sterilization, or shelf-life assumptions can meaningfully affect what data are needed.

 

Finally, many teams underestimate the value of a strong written rationale. Testing alone does not tell the whole story. Regulators want to see how the manufacturer thought through the risks, why specific testing was selected, and how the results support safety for the intended clinical use. The narrative around the data matters.

 

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Rollins: My biggest advice to medical device manufacturers is to think about testing as a strategic enabler, not just a regulatory obligation. When approached correctly, a strong test plan helps de-risk development, improve decision-making, and accelerate market access. When approached too narrowly or too late, it often becomes a source of delay, rework, and unnecessary cost.

 

I would also encourage manufacturers to engage their internal experts and external partners early. The most efficient programs are usually the ones where the team takes time up front to understand the device, identify the real risks, and build a plan that is scientifically grounded and globally informed.

 

Ultimately, the goal is not to run the most tests. The goal is to generate the right evidence at the right time and in the right way to support patient safety and product success.