Getting Ready for Medical Device Testing: What Manufacturers Need to Know

20 Feb 2026

How Early Planning Can Streamline Your Entire Compliance Journey

When we talk to people from startups, mid-sized companies, or large medical device manufacturers, one of the first questions that comes up is, “What does it mean to be ready for testing?” Getting ready isn’t just about having a product in hand. It’s about being fully prepared from documentation to samples and understanding how design decisions can impact testing.

What “Ready for Testing” Really Means

By the time a manufacturer is ready for testing, especially for certification, the design documentation should be frozen. You should have your risk management files, usability evaluations, and any product-specific checklists in hand. You also need a clear idea of your device’s classifications. For example, does your device need to comply with the alarm standard 60601-1-8? Is it intended for the home healthcare environment, requiring compliance with 60601-1-11? Knowing this upfront makes the process much smoother.

Most of the time, manufacturers will be ready to provide a finished product that’s representative of the final device. But labs also work with preliminary early-stage projects, or spot check testing is possible if you’re experimenting with new components, upgrades, or standard updates.

Samples and Accessories: Don’t Overlook the Details

When it comes to actual testing, the number and type of samples can make a big difference. If your product comes in multiple configurations for example, a patient monitor with different pulse oximetry sensors, labs will typically ask for one of each configuration. Accessories also matter. Even small add-ons can have quirks that affect testing outcomes. A common pitfall is not providing all the required components. Missing documentation, mismatched checklist versions, or missing accessories can lead to delays and extra back-and-forth. Being meticulous about what you supply upfront saves both time and money.

Design Changes and Connectivity

Adding new features or changing components may seem minor, but even small design changes can impact testing. Connectivity is a big one. More medical devices now include wireless features like Bluetooth or 5G, even small handheld devices. This can trigger additional EMC testing or affect how your device interacts with other systems.

Similarly, swapping power sources or adding a new battery can require extra tests to ensure safe operation. The key is to look at the biggest picture: how does a change impact ingress protection, access to metal parts, essential performance, or the overall usability of the device?

Even seemingly small adjustments, like software updates for connected devices, must be evaluated to ensure they do not compromise essential performance.

Risk Management Is More Than a Form

Risk management isn’t just paperwork, it’s integral to testing. Think of it as the “cartilage” connecting all parts of your product evaluation. It guides how testing is performed, highlights potential problem areas, and even affects which tests are required. In many cases, risk management can influence test planning more than the device itself.

This is especially true under the current 3rd edition of 60601-1, where thorough documentation and careful risk analysis can prevent delays and avoid unnecessary testing. It’s also worth noting that the upcoming 4th edition will shift focus toward basic safety and essential performance, so getting familiar with this mindset early is key.

Navigating Part-Specific Requirements

Not all devices are the same. Part 2 standards can significantly modify testing requirements. Non-invasive blood pressure monitors, for example, require additional tests, while thermometers change expectations for instrumentation controls and displays. Understanding both Part 1 and Part 2 requirements early prevents surprises and reduces unnecessary testing.

Communication is Key

One of the simplest ways to reduce delays is to communicate early and often. Respond promptly to queries, clarify document revisions, and ask questions about potential design changes. If you’re considering changing the battery, swapping a charger, or updating software, reach out to your lab early to understand what tests will be required.

Manufacturers who do this often see dramatic reductions in testing time. In one case, a client brought a spreadsheet of proposed tests for a handheld thermometer and discussed changes upfront. This allowed the lab to eliminate unnecessary tests and finish the project quickly, a stark contrast to projects where changes were unclear or revealed too late.

Lessons from Real-World Experience

Preparation and clarity pay off. When a manufacturer clearly outlines changes to critical components, documents revisions, and shares a draft test plan, the process is smoother, faster, and less stressful for everyone involved. Conversely, last-minute changes like trying to add new markets or certifications late in the process can create delays and require additional retesting. Being proactive, collaborative, and transparent is the single most effective way to ensure a smooth testing process.

Key Takeaways

• Be prepared: Frozen documentation, risk management files, representative samples, and accessories.
• Think ahead: Even minor design changes or connectivity features can affect testing scope.
• Collaborate early: Share plans, ask questions, and clarify revisions to reduce delays.
• Understand your standards: Part 1 and Part 2 requirements, plus upcoming changes, shape testing.
• Communicate continuously: Responsiveness and transparency save time and money.

The bottom line: successful medical device testing isn’t just about compliance: it’s about preparation, communication, and collaboration. The earlier manufacturers engage in the process, the smoother testing will be, and the faster devices can reach the market safely and efficiently.